Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

June 8, 2021 updated by: Marwa mahmoud Abd El Rady, Assiut University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Asyut
      • Assiut, Asyut, Egypt, 715715
        • Pediatric hospital,assiut university

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: fentanyl
Group F: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + (5ug) of fentanyl intrathecally
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
Other Names:
  • sublimaze
Active Comparator: midazolam
Group M: will receive intrathecal 0.5% bupivacaine (0.3 mg/kg) + 0.5 mg of midazolam intrathecally
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
Other Names:
  • dormicum
Placebo Comparator: Bupivacaine
Group B:intrathecal 0.5% bupivacaine (0.3 mg/kg)
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
Other Names:
  • Bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Principal Investigator: Wesam N Ali, MD, Lecturer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2018

Primary Completion (Actual)

April 20, 2021

Study Completion (Actual)

May 14, 2021

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

July 9, 2018

First Posted (Actual)

July 19, 2018

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fentanyl versus midazolam

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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