Fentanyl Versus Midazolam as an Adjunct to Intrathecal Bupivacaine In Children

• Status: Completed
• Trial end date: 2021-05-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Bupivacaine; Fentanyl; Midazolam

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,