Pain, PostoperativePhase 2NCT04646967
An Evaluation of Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
A Phase 2 study testing Bupivacain, Sevoflurane and Acetaminophen in people with Pain, Postoperative and Phimosis, run by Alberta Children's Hospital at 1 site in Canada.
Trial summary
Circumcision is the most common surgical procedure performed by Pediatric Urologists. Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic regimens without the commonly associated adverse effects. Read more about this study
- Who is it for?
- Ages Up to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Phimosis, Paraphimosis
- What is being tested?
- Bupivacain, Sevoflurane and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 25 Nov 2022to 25 Jan 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All children admitted for circumcision at the Alberta Children's Hospital
Who cannot join
- History of allergic reactions to local anesthetics or ketorolac
- Bleeding diatheses
- Coagulopathy
- Infection at the injection site.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
Circumcision is the most common surgical procedure performed by Pediatric Urologists. Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic regimens without the commonly associated adverse effects. This study aims to see if giving ketorolac during the operation will result in better pain control. We hypothesize that ketorolac will result in pain control similar to morphine with a lower incidence of side effects such as nausea and vomiting.
Read the detailed description
We performed a pilot study in 2017 evaluating the perioperative use of ketorolac in circumcision. Overall, there were no adverse reactions and ketorolac patients did not experience significantly less pain that the control group patients. However, parental perception of pain was lower in the ketorolac group when compared to the control and this required more investigation. Based on our findings of the pilot study, we determined that we needed at least 36 patients in each study group to come to a statistical conclusion. With a larger study group perhaps a statistical difference in pain as measured with a FLACC score may become apparent.
Prospective, randomized, single-blinded study will be conducted from January 2021 - January 2022. A total of two groups will present with 50 children in each group.
A computer-generated randomized block design program will be used to allocate patients to either the treatment (ketorolac) or control (no ketorolac) group. All children will receive a 15 mg/kg oral dose of acetaminophen prior to surgery unless contraindicated. General anesthesia will be induced with sevoflurane via facemask. After establishing venous access, a laryngeal mask will be inserted, and anesthesia maintained with 1 minimum alveolar anesthetic concentration (MAC) of sevoflurane in oxygen/air 50/50 mixture. The DPNB nerve block will be performed by a pediatric urologist using a 23 GA needle inserted below the Buck fascia. Once the needle tip is positioned appropriately, and after a negative aspiration test, 0.2mL/kg (maximum 10mL) of 0.25% bupivacaine is injected in small aliquots, with intermittent aspiration throughout. In all patients, skin incision is performed at least 5 min after placement of the nerve block. At the beginning of the circumcision procedure once the patient is asleep, patients in the treatment group will receive a 0.5 mg/kg intravenous dose of ketorolac. Patients will be advised to take ibuprofen and acetaminophen post-operatively as needed, but not ibuprofen within 6 hours of the procedure. A 6-hour window between ibuprofen and ketorolac is in line with our standard of practice at the Alberta Children's Hospital when using additional NSAIDs after ketorolac.
Patients' demographic information, time needed to perform the block, time of block onset and duration of surgery will be recorded. The mean arterial pressure, heart rate and oxygen saturation, expired sevoflurane end tidal concentration and MAC will be systematically collected pre-operatively, intra-operatively and post-operatively in the recovery room. The primary outcome of post-operative pain will be evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The usage of these two scales will be performed as deemed appropriate by the research assistant. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment (> 7 years of age). The FLACC score is a well-established postoperative pain measure using 5 items scored between 0-2, which has been validated in patients from 6 months up to 7 years of age. These faces are rated on a scale of 10. A FLACC or NRS pain score will be recorded every 15 minutes for the first hour and every 30 minutes for up to 2 hours following discharge from the PACU into the day stay surgical unit. If the score is found to be >3 (moderate pain 4-6, severe pain 7-10), the patient will receive an intravenous morphine dose of 0.05mg/kg. An additional dose may be given 15 minutes following the initial dose of morphine if analgesia is inadequate (score >4). Postoperatively, the child will be monitored every 15 minutes during the first hour and every 30 minutes for the next 2 hours until discharge home. Discharge will be based on normal institutional criteria including level of awareness, hemodynamic stability and absence of pain, bleeding, nausea and vomiting. Prior to discharge, parents will be provided with any additional analgesics required at home and will be contacted 24 hours following their surgery to complete the parents' postoperative pain measure (PPPM). The PPPM is a well-established post-operative pain assessment tool with high inter-rater reliability and construct validity, which has been designed specifically for use by parents in the post-operative care of their children. The measure includes 15 items scored between 0 and 1. The questionnaire will be completed over the telephone at a time corresponding to 24 hours post-surgical closure. Amount of pain and analgesia consumption data will then be collected by contacting the parents 24 hours post procedure.
- Conditions
- Pain, Postoperative, Phimosis, Paraphimosis, Balanitis
- Being tested
- Bupivacain, Sevoflurane, Acetaminophen, Ibuprofen, Ketorolac
- Keywords
- penis, pain, ketorolac, circumcision
- Medical subject headings
- Pain, Postoperative, Phimosis, Paraphimosis, Balanitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Marcaine
See active comparator description
SevofluraneDrug
Also called Sevorane, Ultane, Sojourn
See active comparator description
AcetaminophenDrug
Also called Tylenol
See active comparator description
IbuprofenDrug
Also called Advil
See active comparator description
KetorolacDrug
Also called Toradol
See experimental arm description
| Study group | Role | What they receive |
|---|---|---|
| No ketorolac | Active comparator | 15 mg/kg oral dose of acetaminophen is administered prior to surgery. General anesthesia will be induced with sevoflurane via facemask. After establishing venous access, a laryngeal mask will be inserted, and anesthesia maintained with 1 minimum alveolar anesthetic concentration (MAC) of sevoflurane in oxygen/air 50/50 mixture. The DPNB nerve block is done using a 23 GA needle inserted below the Buck fascia. Once the needle tip is positioned appropriately and after a negative aspiration test, 0.2mL/kg (maximum 10mL) of 0.25% bupivacaine is injected in small aliquots, with intermittent aspiration throughout. In all patients, skin incision is performed at least 5 min after placement of the nerve block. Patients will be advised to take ibuprofen and acetaminophen postoperatively as needed. Receives: Drug: Bupivacain; Drug: Sevoflurane; Drug: Acetaminophen; Drug: Ibuprofen |
| Peri-operative ketorolac | Experimental | Exactly same as the no ketorolac group except at the beginning of the circumcision, once the patient is asleep, patients in the perioperative ketorolac group will also receive a 0.5 mg/kg intravenous dose of ketorolac. Receives: Drug: Bupivacain; Drug: Sevoflurane; Drug: Acetaminophen; Drug: Ibuprofen; Drug: Ketorolac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: Immediately following the procedure
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the Wong-Baker FACES scale will be used in patients capable of self-assessment. Both scores are out of 10 and can be averaged together to quantify post-operative pain
Measured: 15 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 30 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 45 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 60 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 90 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 120 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 150 minutes post-operatively
Post-operative pain
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Measured: 180 minutes post-operatively
Post-operative pain
Evaluated through use of Parents' Post-operative Pain Measure (PPPM) completed via telephone follow-up with parent/guardian 24-hours post-operative.
Measured: 24 hours post-operatively
Secondary outcomes (3)
Total ibuprofen consumption
Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
Measured: 24 hours post-operatively
Total acetaminophen consumption
Evaluated and compiled through anesthesia notes, post-operative nursing care notes and parental telephone follow-up
Measured: 24 hours post-operatively
Incidence of bleeding requiring medical attention
Bleeding events will be compiled through post-anesthetic care unit, surgical short stay unit, clinic and emergency department notes
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start25 Nov 2022
- Primary completion25 Jan 2024
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bryce Weber, Alberta Children's Hospital
- Investigators
- Bryce Weber, MD FRCSC, Principal investigator, Alberta Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646967
- Sponsor's protocol ID
- REB20-1076
- Status last verified
- Aug 2024
- First submitted
- 23 Nov 2020
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allan CY, Jacqueline PA, Shubhda JH. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2003;(2):CD003005. doi: 10.1002/14651858.CD003005.
PubMed 12804449Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004217. doi: 10.1002/14651858.CD004217.pub2.
PubMed 15495086American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
PubMed 22227789Adler R, Ottaway MS, Gould S. Circumcision: we have heard from the experts; now let's hear from the parents. Pediatrics. 2001 Feb;107(2):E20. doi: 10.1542/peds.107.2.e20.
PubMed 11158494Sutters KA, Levine JD, Dibble S, Savedra M, Miaskowski C. Analgesic efficacy and safety of single-dose intramuscular ketorolac for postoperative pain management in children following tonsillectomy. Pain. 1995 Apr;61(1):145-153. doi: 10.1016/0304-3959(94)00166-C.
PubMed 7644238Gunter JB, Varughese AM, Harrington JF, Wittkugel EP, Patankar SS, Matar MM, Lowe EE, Myer CM 3rd, Willging JP. Recovery and complications after tonsillectomy in children: a comparison of ketorolac and morphine. Anesth Analg. 1995 Dec;81(6):1136-41. doi: 10.1097/00000539-199512000-00004.
PubMed 7486094De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
PubMed 21965355von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.
PubMed 16996689Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
PubMed 9220806Chambers CT, Hardial J, Craig KD, Court C, Montgomery C. Faces scales for the measurement of postoperative pain intensity in children following minor surgery. Clin J Pain. 2005 May-Jun;21(3):277-85. doi: 10.1097/00002508-200505000-00011.
PubMed 15818080Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
PubMed 14527704Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 4.4: 287-291, 2005
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial Evaluating Pain Outcomes of Ketorolac Administration in Children Undergoing Circumcision
- ClinicalTrials.gov ID
- NCT04646967
- Acronym / sponsor ID
- REB20-1076
- Conditions
- Pain, Postoperative, Phimosis, Paraphimosis, Balanitis
- Keywords
- penis, pain, ketorolac, circumcision
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Alberta Children's HospitalUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 30 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Circumcision is the most common surgical procedure performed by Pediatric Urologists. Ketorolac has been shown to have an efficacy similar to morphine in multi-modal analgesic regimens without the commonly associated adverse effects. This study aims to see if giving ketorolac during the operation will result in better pain control. We hypothesize that ketorolac will result in pain control similar to morphine with a lower incidence of side effects such as nausea and vomiting.
Detailed description
We performed a pilot study in 2017 evaluating the perioperative use of ketorolac in circumcision. Overall, there were no adverse reactions and ketorolac patients did not experience significantly less pain that the control group patients. However, parental perception of pain was lower in the ketorolac group when compared to the control and this required more investigation. Based on our findings of the pilot study, we determined that we needed at least 36 patients in each study group to come to a statistical conclusion. With a larger study group perhaps a statistical difference in pain as measured with a FLACC score may become apparent.
Prospective, randomized, single-blinded study will be conducted from January 2021 - January 2022. A total of two groups will present with 50 children in each group.
A computer-generated randomized block design program will be used to allocate patients to either the treatment (ketorolac) or control (no ketorolac) group. All children will receive a 15 mg/kg oral dose of acetaminophen prior to surgery unless contraindicated. General anesthesia will be induced with sevoflurane via facemask. After establishing venous access, a laryngeal mask will be inserted, and anesthesia maintained with 1 minimum alveolar anesthetic concentration (MAC) of sevoflurane in oxygen/air 50/50 mixture. The DPNB nerve block will be performed by a pediatric urologist using a 23 GA needle inserted below the Buck fascia. Once the needle tip is positioned appropriately, and after a negative aspiration test, 0.2mL/kg (maximum 10mL) of 0.25% bupivacaine is injected in small aliquots, with intermittent aspiration throughout. In all patients, skin incision is performed at least 5 min after placement of the nerve block. At the beginning of the circumcision procedure once the patient is asleep, patients in the treatment group will receive a 0.5 mg/kg intravenous dose of ketorolac. Patients will be advised to take ibuprofen and acetaminophen post-operatively as needed, but not ibuprofen within 6 hours of the procedure. A 6-hour window between ibuprofen and ketorolac is in line with our standard of practice at the Alberta Children's Hospital when using additional NSAIDs after ketorolac.
Patients' demographic information, time needed to perform the block, time of block onset and duration of surgery will be recorded. The mean arterial pressure, heart rate and oxygen saturation, expired sevoflurane end tidal concentration and MAC will be systematically collected pre-operatively, intra-operatively and post-operatively in the recovery room. The primary outcome of post-operative pain will be evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The usage of these two scales will be performed as deemed appropriate by the research assistant. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment (> 7 years of age). The FLACC score is a well-established postoperative pain measure using 5 items scored between 0-2, which has been validated in patients from 6 months up to 7 years of age. These faces are rated on a scale of 10. A FLACC or NRS pain score will be recorded every 15 minutes for the first hour and every 30 minutes for up to 2 hours following discharge from the PACU into the day stay surgical unit. If the score is found to be >3 (moderate pain 4-6, severe pain 7-10), the patient will receive an intravenous morphine dose of 0.05mg/kg. An additional dose may be given 15 minutes following the initial dose of morphine if analgesia is inadequate (score >4). Postoperatively, the child will be monitored every 15 minutes during the first hour and every 30 minutes for the next 2 hours until discharge home. Discharge will be based on normal institutional criteria including level of awareness, hemodynamic stability and absence of pain, bleeding, nausea and vomiting. Prior to discharge, parents will be provided with any additional analgesics required at home and will be contacted 24 hours following their surgery to complete the parents' postoperative pain measure (PPPM). The PPPM is a well-established post-operative pain assessment tool with high inter-rater reliability and construct validity, which has been designed specifically for use by parents in the post-operative care of their children. The measure includes 15 items scored between 0 and 1. The questionnaire will be completed over the telephone at a time corresponding to 24 hours post-surgical closure. Amount of pain and analgesia consumption data will then be collected by contacting the parents 24 hours post procedure.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No ketorolac | Active comparator | Drug: Bupivacain, Drug: Sevoflurane, Drug: Acetaminophen, Drug: Ibuprofen15 mg/kg oral dose of acetaminophen is administered prior to surgery. General anesthesia will be induced with sevoflurane via facemask. After establishing venous access, a laryngeal mask will be inserted, and anesthesia maintained with 1 minimum alveolar anesthetic concentration (MAC) of sevoflurane in oxygen/air 50/50 mixture. The DPNB nerve block is done using a 23 GA needle inserted below the Buck fascia. Once the needle tip is positioned appropriately and after a negative aspiration test, 0.2mL/kg (maximum 10mL) of 0.25% bupivacaine is injected in small aliquots, with intermittent aspiration throughout. In all patients, skin incision is performed at least 5 min after placement of the nerve block. Patients will be advised to take ibuprofen and acetaminophen postoperatively as needed. |
| Peri-operative ketorolac | Experimental | Drug: Bupivacain, Drug: Sevoflurane, Drug: Acetaminophen, Drug: Ibuprofen, Drug: KetorolacExactly same as the no ketorolac group except at the beginning of the circumcision, once the patient is asleep, patients in the perioperative ketorolac group will also receive a 0.5 mg/kg intravenous dose of ketorolac. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All children admitted for circumcision at the Alberta Children's Hospital
Key exclusion criteria (4 listed)
- History of allergic reactions to local anesthetics or ketorolac
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacainAlso: MarcaineSee active comparator description | Drug | No ketorolac, Peri-operative ketorolac |
| SevofluraneAlso: Sevorane, Ultane, SojournSee active comparator description | Drug | No ketorolac, Peri-operative ketorolac |
| AcetaminophenAlso: TylenolSee active comparator description | Drug | No ketorolac, Peri-operative ketorolac |
| IbuprofenAlso: AdvilSee active comparator description | Drug | No ketorolac, Peri-operative ketorolac |
| KetorolacAlso: ToradolSee experimental arm description | Drug | Peri-operative ketorolac |
Primary outcome
Post-operative pain
Time frame: Immediately following the procedure
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 15 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the Wong-Baker FACES scale will be used in patients capable of self-assessment. Both scores are out of 10 and can be averaged together to quantify post-operative pain
Post-operative pain
Time frame: 30 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 45 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 60 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 90 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 120 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 150 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 180 minutes post-operatively
Evaluated through the use of the Face, Legs, Activity, Cry, Consolability (FLACC) pain score or Numerical Rating Scale (NRS) pain score ascertained by a nurse or research assistant blinded to the anesthetic technique. The FLACC scale will be used in children who have difficulty verbalizing pain and in sleeping children (regardless of age) while the NRS pain score will be used in patients capable of self-assessment.
Post-operative pain
Time frame: 24 hours post-operatively
Evaluated through use of Parents' Post-operative Pain Measure (PPPM) completed via telephone follow-up with parent/guardian 24-hours post-operative.
3 secondary outcomes
Total ibuprofen consumption
Time frame: 24 hours post-operatively
Total acetaminophen consumption
Time frame: 24 hours post-operatively
Incidence of bleeding requiring medical attention
Time frame: Up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 12804449Allan CY, Jacqueline PA, Shubhda JH. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2003;(2):CD003005. doi: 10.1002/14651858.CD003005.
- Background: PubMed 15495086Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004217. doi: 10.1002/14651858.CD004217.pub2.
- Background: PubMed 22227789American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012 Feb;116(2):248-73. doi: 10.1097/ALN.0b013e31823c1030. No abstract available.
- Background: PubMed 11158494Adler R, Ottaway MS, Gould S. Circumcision: we have heard from the experts; now let's hear from the parents. Pediatrics. 2001 Feb;107(2):E20. doi: 10.1542/peds.107.2.e20.
- Background: PubMed 7644238Sutters KA, Levine JD, Dibble S, Savedra M, Miaskowski C. Analgesic efficacy and safety of single-dose intramuscular ketorolac for postoperative pain management in children following tonsillectomy. Pain. 1995 Apr;61(1):145-153. doi: 10.1016/0304-3959(94)00166-C.
- Background: PubMed 7486094Gunter JB, Varughese AM, Harrington JF, Wittkugel EP, Patankar SS, Matar MM, Lowe EE, Myer CM 3rd, Willging JP. Recovery and complications after tonsillectomy in children: a comparison of ketorolac and morphine. Anesth Analg. 1995 Dec;81(6):1136-41. doi: 10.1097/00000539-199512000-00004.
- Background: PubMed 21965355De Oliveira GS Jr, Agarwal D, Benzon HT. Perioperative single dose ketorolac to prevent postoperative pain: a meta-analysis of randomized trials. Anesth Analg. 2012 Feb;114(2):424-33. doi: 10.1213/ANE.0b013e3182334d68. Epub 2011 Sep 29.
- Background: PubMed 16996689von Baeyer CL, Spagrud LJ. Systematic review of observational (behavioral) measures of pain for children and adolescents aged 3 to 18 years. Pain. 2007 Jan;127(1-2):140-50. doi: 10.1016/j.pain.2006.08.014. Epub 2006 Sep 25.
- Background: PubMed 9220806Merkel SI, Voepel-Lewis T, Shayevitz JR, Malviya S. The FLACC: a behavioral scale for scoring postoperative pain in young children. Pediatr Nurs. 1997 May-Jun;23(3):293-7.
- Background: PubMed 15818080Chambers CT, Hardial J, Craig KD, Court C, Montgomery C. Faces scales for the measurement of postoperative pain intensity in children following minor surgery. Clin J Pain. 2005 May-Jun;21(3):277-85. doi: 10.1097/00002508-200505000-00011.
- Background: PubMed 14527704Chambers CT, Finley AG, McGrath PJ, Walsh TM. The parents' postoperative pain measure: replication and extension to 2-6-year-old children. Pain. 2003 Oct;105(3):437-443. doi: 10.1016/S0304-3959(03)00256-2.
- BackgroundJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics 4.4: 287-291, 2005
- Ketorolac compound summary. Pubchem Substance Website. National Center for Biotechnology, US National Library of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bryce Weber, MD FRCSC principal investigator
Alberta Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bupivacain, Sevoflurane and Acetaminophen in people with Pain, Postoperative and Phimosis, run by Alberta Children's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: Immediately following the procedure). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646967, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2024.