Postoperative AnalgesiaPhase 2/3NCT03592537
Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children
A Phase 2/3 study testing Fentanyl, Midazolam and Bupivacaine Hydrochloride in people with Postoperative Analgesia, run by Assiut University at 1 site in Egypt.
Trial summary
The primary aim of the present study will be to compare the analgesic effect of addition of fentanyl or midazolam to intrathecal bupivacaine by using CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body… Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Fentanyl, Midazolam and Bupivacaine Hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2018to 14 May 2021
- 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 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6-8years
- undergoing infra-umbilical surgery.
Who cannot join
- Children with a known history of bleeding diathesis,
- allergy to local anesthetics,
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Pediatric hospital,assiut university
Asyut, Asyut Governorate, 715715
About this study
Official title: Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine for Postoperative Analgesia in Children Undergoing Infraumbilical Surgery
The primary aim of the present study will be to compare the analgesic effect of addition of fentanyl or midazolam to intrathecal bupivacaine by using CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.
Secondary outcomes of study will be;
- is to compare the duration of postoperative analgesia.
- comparative assessment regarding time for first analgesic request ,total analgesic requirements.
- Hemodynamic changes or other adverse events will be recorded.
Read the detailed description
Spinal anesthesia (SA) in pediatrics began to be used in the late nineteenth century in multiple procedures, with the priority for high-risk and former preterm infants, for its suggested protective role compared to the development of postoperative apnea with general anesthesia (GA) . Regional anesthesia offers several advantages over general anesthesia-blunts stress response to surgery, decreases intraoperative blood loss, lowers the incidence of postoperative thromboembolic events, and provides analgesia in early postoperative period .
Spinal anesthesia has been Proposed as a means to reduce postoperative complications especially apnea and postoperative respiratory dysfunction. Prolongation of pain relief can be accomplished by various adjuvants like opioids (morphine, fentanyl, ketamine and clonidine. However, each drug has its limitations and side effects, and the need for an alternative methods and drugs always exists. Of the several opioids available for neuro-axial administration, morphine and fentanyl remain the most commonly used agents. Because of the more lipophilic nature of fentanyl, it has a more rapid onset of action than morphine.
Intrathecal fentanyl produce profound analgesia by making direct contact with the substantia-gelatinosa of the cord and it also provides cephalad extend of sensorial block. The addition of intrathecal fentanyl to spinal anesthesia improves the intraoperative and the early postoperative quality of analgesia, relieves visceral pain and attenuates sympathetic activation during surgery . The addition of intrathecal midazolam gives the best prophylaxis against intraoperative and postoperative nausea and vomiting , also various studies have shown that the analgesic effect of intrathecal bupivacaine is enhanced by intrathecal midazolam without producing significant side effects.
- Conditions
- Postoperative Analgesia
- Keywords
- Fentanyl versus midazolam
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FentanylDrug
Also called sublimaze
The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia patient care or in data collection. Children will be randomly allocated into three groups of 30 children
MidazolamDrug
Also called dormicum
The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children
Bupivacaine HydrochlorideDrug
Also called Bupivacaine
The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children
| Study group | Role | What they receive |
|---|---|---|
| fentanyl | Active comparator | Group F: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + (5ug) of fentanyl intrathecally Receives: Drug: Fentanyl |
| midazolam | Active comparator | Group M: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + 0.5 mg of midazolam intrathecally Receives: Drug: Midazolam |
| Bupivacaine | Placebo comparator | Group B:intrathecal 0.5% bupivacaine (0.3 mg/kg) Receives: Drug: Bupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia
CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.
Measured: 24 hours
Secondary outcomes (1)
to compare the duration of postoperative analgesia. comparative assessment regarding time for first analgesic request ,total analgesic requirements and any adverse effects.
Measured: 24hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start15 Aug 2018
- Primary completion20 Apr 2021
- Study completion14 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies 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
- Model description
- comparison of the effect of intrathecal fentanyl with the effect of intrathecal midazolam as postoperative analgesia in children undergoing infraumbilical surgery
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa mahmoud Abd El Rady, Assiut University
- Investigators
- Wesam N Ali, MD, Principal investigator, lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592537
- Sponsor's protocol ID
- Fentanyl versus midazolam
- Status last verified
- Jun 2021
- First submitted
- 28 Mar 2018
- Last updated
- 10 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chattopadhyay A, Maitra S, Sen S, Bhattacharjee S, Layek A, Pal S, Ghosh K. A study to compare the analgesic efficacy of intrathecal bupivacaine alone with intrathecal bupivacaine midazolam combination in patients undergoing elective infraumbilical surgery. Anesthesiol Res Pract. 2013;2013:567134. doi: 10.1155/2013/567134. Epub 2013 May 15.
PubMed 23762043Duman A, Apiliogullari S, Duman I. Effects of intrathecal fentanyl on quality of spinal anesthesia in children undergoing inguinal hernia repair. Paediatr Anaesth. 2010 Jun;20(6):530-6. doi: 10.1111/j.1460-9592.2010.03315.x. Epub 2010 Apr 23.
PubMed 20456062Dodawad R, G B S, Pandarpurkar S, Jajee P. Intrathecal Midazolam as an Adjuvant in Pregnancy-Induced Hypertensive Patients Undergoing an Elective Caesarean Section: A Clinical Comparative Study. Anesth Pain Med. 2016 Jul 26;6(5):e38550. doi: 10.5812/aapm.38550. eCollection 2016 Oct.
PubMed 27847698Lopez T, Sanchez FJ, Garzon JC, Muriel C. Spinal anesthesia in pediatric patients. Minerva Anestesiol. 2012 Jan;78(1):78-87. doi: 10.1111/j.1460-9592.2011.03769.x. Epub 2011 Dec 28.
PubMed 22211775Sanwatsarkar S, Kapur S, Saxena D, Yadav G, Khan NN. Comparative study of caudal clonidine and midazolam added to bupivacaine during infra-umbilical surgeries in children. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):241-247. doi: 10.4103/0970-9185.209739.
PubMed 28781453
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine for Postoperative Analgesia in Children Undergoing Infraumbilical Surgery
- ClinicalTrials.gov ID
- NCT03592537
- Acronym / sponsor ID
- Fentanyl versus midazolam
- Conditions
- Postoperative Analgesia
- Keywords
- Fentanyl versus midazolam
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 14 May 2021 (actual)
- First posted
- 19 Jul 2018 (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.
The primary aim of the present study will be to compare the analgesic effect of addition of fentanyl or midazolam to intrathecal bupivacaine by using CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.
Secondary outcomes of study will be;
- is to compare the duration of postoperative analgesia.
- comparative assessment regarding time for first analgesic request ,total analgesic requirements.
- Hemodynamic changes or other adverse events will be recorded.
Detailed description
Spinal anesthesia (SA) in pediatrics began to be used in the late nineteenth century in multiple procedures, with the priority for high-risk and former preterm infants, for its suggested protective role compared to the development of postoperative apnea with general anesthesia (GA) . Regional anesthesia offers several advantages over general anesthesia-blunts stress response to surgery, decreases intraoperative blood loss, lowers the incidence of postoperative thromboembolic events, and provides analgesia in early postoperative period .
Spinal anesthesia has been Proposed as a means to reduce postoperative complications especially apnea and postoperative respiratory dysfunction. Prolongation of pain relief can be accomplished by various adjuvants like opioids (morphine, fentanyl, ketamine and clonidine. However, each drug has its limitations and side effects, and the need for an alternative methods and drugs always exists. Of the several opioids available for neuro-axial administration, morphine and fentanyl remain the most commonly used agents. Because of the more lipophilic nature of fentanyl, it has a more rapid onset of action than morphine.
Intrathecal fentanyl produce profound analgesia by making direct contact with the substantia-gelatinosa of the cord and it also provides cephalad extend of sensorial block. The addition of intrathecal fentanyl to spinal anesthesia improves the intraoperative and the early postoperative quality of analgesia, relieves visceral pain and attenuates sympathetic activation during surgery . The addition of intrathecal midazolam gives the best prophylaxis against intraoperative and postoperative nausea and vomiting , also various studies have shown that the analgesic effect of intrathecal bupivacaine is enhanced by intrathecal midazolam without producing significant side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- comparison of the effect of intrathecal fentanyl with the effect of intrathecal midazolam as postoperative analgesia in children undergoing infraumbilical surgery
| Arm | Type | Receives |
|---|---|---|
| fentanyl | Active comparator | Drug: FentanylGroup F: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + (5ug) of fentanyl intrathecally |
| midazolam | Active comparator | Drug: MidazolamGroup M: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + 0.5 mg of midazolam intrathecally |
| Bupivacaine | Placebo comparator | Drug: Bupivacaine HydrochlorideGroup B:intrathecal 0.5% bupivacaine (0.3 mg/kg) |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 6-8years
- undergoing infra-umbilical surgery.
Key exclusion criteria (2 listed)
- Children with a known history of bleeding diathesis,
- allergy to local anesthetics,
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 |
|---|---|---|
| FentanylAlso: sublimazeThe study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia patient care or in data collection. Children will be randomly allocated into three groups of 30 children | Drug | fentanyl |
| MidazolamAlso: dormicumThe study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children | Drug | midazolam |
| Bupivacaine HydrochlorideAlso: BupivacaineThe study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children | Drug | Bupivacaine |
Primary outcome
postoperative analgesia
Time frame: 24 hours
CHEOPS pain score (Children's Hospital Eastern Ontario Pain Scale) which is based on 6 criteria: crying, facial expression, child verbal expression, torso (body position), touching or grabbing at wound and legs position. Criterion 1 is given a score of 1-3, criteria 2 and 3 are given a score of 0-2 while criteria 4, 5 and 6 are given a score of 1-2; making the worst possible score 13 while the least possible score is 4. A total score ⩽ than 6 indicates adequate analgesia.
1 secondary outcome
to compare the duration of postoperative analgesia. comparative assessment regarding time for first analgesic request ,total analgesic requirements and any adverse effects.
Time frame: 24hour
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 10 Jun 2021.
- Results publication: PubMed 23762043Chattopadhyay A, Maitra S, Sen S, Bhattacharjee S, Layek A, Pal S, Ghosh K. A study to compare the analgesic efficacy of intrathecal bupivacaine alone with intrathecal bupivacaine midazolam combination in patients undergoing elective infraumbilical surgery. Anesthesiol Res Pract. 2013;2013:567134. doi: 10.1155/2013/567134. Epub 2013 May 15.
- Results publication: PubMed 20456062Duman A, Apiliogullari S, Duman I. Effects of intrathecal fentanyl on quality of spinal anesthesia in children undergoing inguinal hernia repair. Paediatr Anaesth. 2010 Jun;20(6):530-6. doi: 10.1111/j.1460-9592.2010.03315.x. Epub 2010 Apr 23.
- Results publication: PubMed 27847698Dodawad R, G B S, Pandarpurkar S, Jajee P. Intrathecal Midazolam as an Adjuvant in Pregnancy-Induced Hypertensive Patients Undergoing an Elective Caesarean Section: A Clinical Comparative Study. Anesth Pain Med. 2016 Jul 26;6(5):e38550. doi: 10.5812/aapm.38550. eCollection 2016 Oct.
- Results publication: PubMed 22211775Lopez T, Sanchez FJ, Garzon JC, Muriel C. Spinal anesthesia in pediatric patients. Minerva Anestesiol. 2012 Jan;78(1):78-87. doi: 10.1111/j.1460-9592.2011.03769.x. Epub 2011 Dec 28.
- Results publication: PubMed 28781453Sanwatsarkar S, Kapur S, Saxena D, Yadav G, Khan NN. Comparative study of caudal clonidine and midazolam added to bupivacaine during infra-umbilical surgeries in children. J Anaesthesiol Clin Pharmacol. 2017 Apr-Jun;33(2):241-247. doi: 10.4103/0970-9185.209739.
Related trials for Postoperative Analgesia
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
RecruitingObservational study
Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain
Amputation, Amputation of Lower Limb
Recruiting
Conditioned Open Label Placebo for Postoperative Pain Management
Pain, Postoperative
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.
Wesam N Ali, MD principal investigator
lecturer
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 Fentanyl, Midazolam and Bupivacaine Hydrochloride in people with Postoperative Analgesia, 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 2 inclusion and 2 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 10 Jun 2021. 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. Some participants in this study may receive a placebo. 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?
postoperative analgesia (time frame: 24 hours). 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 NCT03592537, which also lists 5 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 10 Jun 2021.