Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

NCT ID: NCT03592537

Last Updated: 2021-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-15
• Study Completion Date: 2021-05-14

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

fentanyl

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

Group Type: ACTIVE_COMPARATOR

Fentanyl

Intervention Type: 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

midazolam

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: 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

Bupivacaine

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

Group Type: PLACEBO_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type: 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

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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

Intervention Type: DRUG

Other Intervention Names

sublimaze; dormicum; Bupivacaine

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Marwa mahmoud Abd El Rady

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wesam N Ali, MD

Role: PRINCIPAL_INVESTIGATOR

lecturer

Locations

Pediatric hospital,assiut university

Asyut, Asyut Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 23762043 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20456062 (View on PubMed)

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.

Reference Type: RESULT

PMID: 27847698 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22211775 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28781453 (View on PubMed)

Other Identifiers

Fentanyl versus midazolam

Identifier Type: -

Identifier Source: org_study_id