The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery

Phase 4

Completed

• Conditions: Failed Moderate Sedation During Procedure
• Interventions: Drug: 1 mL/kg bupivacaine 0.25%.

• Registration Number: NCT02127489
• Lead Sponsor: Karadeniz Technical University

Brief Summary

This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.

Detailed Description

Summary Background: This study aimed to compare the efficiency of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, sedation, and to find out its adverse effects in children having lower abdominal surgery.

Methods: 40 children between 2 and 10 years of American Society of Anesthesiologist (ASA) I-II stages were randomized and applied caudal anesthesia under general anesthesia. Patients were applied caudal block in addition with saline and 1milliliter/kilograms (mL/kg) bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5 milliliter (mL) saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.

Study Timeline

• Study Start: 2005-06
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2014-04
• Study First Submitted: 2014-04-18
• Study First Submitted QC: 2014-04-28
• Last Update Submitted: 2014-04-28
• Study First Posted: 2014-04-30
• Last Update Posted: 2014-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• children having lower abdominal surgery

Exclusion Criteria

• Children with significant respiratory system, circulatory system, liver, and kidney function disorder, history of allergy to the drugs to be studied, those who received analgesic medication before the operation, and those for whom caudal anesthesia is contraindicated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Midazolam	1 mL/kg bupivacaine 0.25%.	1 mL/kg bupivacaine 0.25%.
saline	1 mL/kg bupivacaine 0.25%.	5mL rectal saline

Primary Outcome Measures

Name	Time	Method
Sedation scale and postoperative pain scale (CHIPPS)	24 hours	Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.

Trial Locations

Locations (1)

Karadeniz Technical University Faculty of Medicine; 🇹🇷 Trabzon, Turkey