Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

Postoperative Analgesia Clinical Trial

Official title:

Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine for Postoperative Analgesia in Children Undergoing Infraumbilical Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592537
• Other study ID #: Fentanyl versus midazolam
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 15, 2018
• Est. completion date: May 14, 2021

Study information

• Verified date: June 2021
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: May 14, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 8 Years

Eligibility

Inclusion Criteria:

• children aged 6-8years

• undergoing infra-umbilical surgery.

Exclusion Criteria:

• Children with a known history of bleeding diathesis,

• allergy to local anesthetics,

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Drug:
• Fentanyl
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
• Midazolam
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 Hydrochloride
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

Locations

Country	Name	City	State
Egypt	Pediatric hospital,assiut university	Assiut	Asyut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & 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 surger — View Citation

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. eCollection 2016 O — View Citation

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. — View Citation

López T, Sánchez FJ, Garzón 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. Review. — View Citation

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: 10.4103/0970-9185.2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	to compare the duration of postoperative analgesia. comparative assessment regarding time for first analgesic request ,total analgesic requirements and any adverse effects.		24hour