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Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

NCT03592537 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-06-10

No results posted yet for this study

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

Interventions

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

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

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

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Principal Investigators

  • Wesam N Ali, MD · lecturer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2021-04-20
Completion
2021-05-14

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03592537 on ClinicalTrials.gov