Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

NCT03592537 | Completed Phase 2 DMC

• 1 other identifier: Fentanyl versus midazolam
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Postoperative Analgesia

Keywords

Fentanyl versus midazolam

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  24hour

Study Arms (3)

fentanyl

ACTIVE COMPARATOR

Group F: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + (5ug) of fentanyl intrathecally

Drug: Fentanyl

midazolam

ACTIVE COMPARATOR

Group M: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + 0.5 mg of midazolam intrathecally

Drug: Midazolam

Bupivacaine

PLACEBO COMPARATOR

Group B:intrathecal 0.5% bupivacaine (0.3 mg/kg)

Drug: Bupivacaine Hydrochloride

Interventions

Fentanyl DRUG

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

Also known as: sublimaze

fentanyl

Midazolam DRUG

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

Also known as: dormicum

midazolam

Bupivacaine Hydrochloride DRUG

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

Also known as: Bupivacaine

Bupivacaine

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children aged 6-8years
• undergoing infra-umbilical surgery.

You may not qualify if:

• Children with a known history of bleeding diathesis,
• allergy to local anesthetics,

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Pediatric hospital,assiut university

Asyut, Asyut Governorate, 715715, Egypt

Location

Related Publications (5)

• 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.

  PMID: 23762043 RESULT

• Duman 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.

  PMID: 20456062 RESULT

• Dodawad 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.

  PMID: 27847698 RESULT

• Lopez 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.

  PMID: 22211775 RESULT

• Sanwatsarkar 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.

  PMID: 28781453 RESULT

MeSH Terms

Interventions

Fentanyl; Midazolam; Bupivacaine

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Wesam N Ali, MD

  lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care provider, Investigator, Outcomes Assessor) The trial will be planned that neither the doctors nor the patients will be aware of the group allocations. The study drugs will be prepared by an anesthesiologist not involved in performing the aneshesia, patient care or in data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: comparison of the effect of intrathecal fentanyl with the effect of intrathecal midazolam as postoperative analgesia in children undergoing infraumbilical surgery

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: July 19, 2018
• Study Start: August 15, 2018
• Primary Completion: April 20, 2021
• Study Completion: May 14, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Locations

EG (1)