Postoperative PainPhase 2/3TKversusCKNCT02462174
Topical Ketamine Versus Caudal Ketamine for Postoperative Analgesia in Children Undergoing Inguinal Herniotomy
A Phase 2/3 study testing Ketamine and Bupivacaine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine. Read more about this study
- Who is it for?
- Ages 6 months to 6 years, men only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Ketamine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- May 2015to Sep 2015
- Phase
- Phase 2/3
- 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 6 months to 6 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- age (6 months to 6 years)
- ASA physical status I or II.
- Operation: elective unilateral inguinal herniotomy.
Who cannot join
- A history of developmental delay or mental retardation,
- Known or suspected coagulopathy,
- Known allergy to any local anaesthetic,
- Known congenital anomaly of the spine or signs of spinal anomaly,
- Infection at the sacral region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
Read the detailed description
The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.
- Conditions
- Postoperative Pain
- Being tested
- Ketamine, Bupivacaine
- Keywords
- anesthesia, analgesia, caudal, ketamine, bupivacaine
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Also called Katalar
0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
KetamineDrug
Also called Katalar
0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
BupivacaineDrug
Also called bucaine
1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
BupivacaineDrug
Also called bucaine
0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure
| Study group | Role | What they receive |
|---|---|---|
| Topical ketamine and topical bupivacaine | Active comparator | 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound. Receives: Drug: Ketamine; Drug: Bupivacaine |
| Caudal ketamine and caudal bupivacaine | Active comparator | 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery. Receives: Drug: Ketamine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first request for postoperative analgesia
time in hours from admission to PACU till first request for analgesia
Measured: 48 hours postoperative
Secondary outcomes (8)
total consumption of postoperative analgesics
the amount of analgesic drugs in mg given in the first 48h postoperative
Measured: 48 hours postoperative
The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score
Measured: 180 minutes postoperative
Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
Measured: 180 minutes postoperative.
the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness).
Measured: 60 minutes postoperative
parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).
the score will be recorded once at the end of the study
Measured: 48 hours postoperative
noninvasive blood pressure
Measured: Intra-operative
heart rate
Measured: Intra-operative
Verbal Numeric Rating Scale (VNRS)
the pain score will be assessed at frequent intervals in the 1st 48 h postoperative
Measured: 48 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2015 (estimated)
- Study startMay 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hala Saad Abdel-Ghaffar, Assiut University
- Investigators
- Hala S Abdel-Ghaffar, MD, Principal investigator, Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02462174
- Sponsor's protocol ID
- IRB00008718/ NF
- Acronym
- TKversusCK
- Status last verified
- Oct 2015
- First submitted
- 29 May 2015
- Last updated
- 2 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caudal Epidural Block Versus Topical Ketamine Application for Postoperative Pain Relief After Elective Inguinal Herniotomy
- ClinicalTrials.gov ID
- NCT02462174
- Acronym / sponsor ID
- TKversusCK / IRB00008718/ NF
- Conditions
- Postoperative Pain
- Keywords
- anesthesia, analgesia, caudal, ketamine, bupivacaine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Jun 2015 (estimated)
- 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.
To find alternatives to caudal analgesia that could be more safe and effective and to demonstrate the analgesic efficacy of topical ketamine.
Detailed description
The most commonly performed inguinal surgeries in children include inguinal hernia repair with or without orchidopexy (orchiopexy). Eighty children aged 6 months to 6 yr of ASA physical status I or II, undergoing elective unilateral inguinal herniotomy will be included. In caudal group, patients will receive a mixture of 0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route after anesthesia and before start of surgery. In topical group, at the end of the procedure, after identification and ligation of the hernial sac, a mixture of 0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord and upon the ilioinguinal nerve in a fan shaped manner by the surgeon. The primary outcome measure will be the time to first request for analgesia. Secondary outcome measures will include the number of analgesic doses required in the first 24 h postoperative, pain scores, sensory and motor block, agitation scores, parent satisfaction and adverse effects in the first 48h postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical ketamine and topical bupivacaine | Active comparator | Drug: Ketamine, Drug: Bupivacaine0.5 mg/ kg ketamine in 0.3 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered directly around the spermatic cord in the wound after end of surgery and before closure of the wound. |
| Caudal ketamine and caudal bupivacaine | Active comparator | Drug: Ketamine, Drug: Bupivacaine0.5 mg/ kg ketamine in 1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) administered by caudal epidural route after anesthesia and before the start of surgery. |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age (6 months to 6 years)
- ASA physical status I or II.
- Operation: elective unilateral inguinal herniotomy.
Key exclusion criteria (5 listed)
- A history of developmental delay or mental retardation,
- Known or suspected coagulopathy,
- Known allergy to any local anaesthetic,
- Known congenital anomaly of the spine or signs of spinal anomaly,
- Infection at the sacral region.
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 |
|---|---|---|
| KetamineAlso: Katalar0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery. | Drug | Topical ketamine and topical bupivacaine |
| KetamineAlso: Katalar0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure. | Drug | Caudal ketamine and caudal bupivacaine |
| BupivacaineAlso: bucaine1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route | Drug | Topical ketamine and topical bupivacaine |
| BupivacaineAlso: bucaine0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure | Drug | Caudal ketamine and caudal bupivacaine |
Primary outcome
time to first request for postoperative analgesia
Time frame: 48 hours postoperative
time in hours from admission to PACU till first request for analgesia
8 secondary outcomes
total consumption of postoperative analgesics
Time frame: 48 hours postoperative
The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS, 0-10) pain score
Time frame: 180 minutes postoperative
Faces Legs Activity Cry Consolability tool (FLACC, 0-10).
Time frame: 180 minutes postoperative.
the agitation score (0= child is asleep, 1= awake/calm, 2= irritable/ consolable cry, 3=inconsolable cry, 4= the child is agitating and thrashing and restlessness).
Time frame: 60 minutes postoperative
parent's satisfaction on a four-point Likert scale (1, excellent; 2, good; 3, fair; 4, poor).
Time frame: 48 hours postoperative
noninvasive blood pressure
Time frame: Intra-operative
heart rate
Time frame: Intra-operative
Verbal Numeric Rating Scale (VNRS)
Time frame: 48 hours postoperative
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 Oct 2015.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Hala S Abdel-Ghaffar, MD principal investigator
Assisstant professor in Anesthesia and intensive care department, faculty of medicine, Assiut university, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ketamine and Bupivacaine in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 5 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 Oct 2015. 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 Egypt. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
time to first request for postoperative analgesia (time frame: 48 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2015.