At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 40 enrolled

Drug / intervention

1 mL/kg bupivacaine 0.25%.drug

Likely dose

1 mL/kg bupivacaine 0.25%.from record

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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02127489

NCT02127489Phase 4Completed

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The Effects of Single-dose Rectal Midazolam Application on Post-operative Recovery, Sedation, and Analgesia in Children Given Caudal Anesthesia Plus Bupivacaine

Karadeniz Technical University·interventional·Posted Apr 30, 2014·Updated Apr 30, 2014

In Brief

A Phase 4 clinical trial evaluating 1 mL/kg bupivacaine 0.25%. for Failed Moderate Sedation During Procedure. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsFailed Moderate Sedation During Procedure

CountriesTurkey (Türkiye)

Collaborators--

Timeline

Phase 4CompletedFinished

20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartJun 2005

Primary CompletionJun 2006

First PostedApr 2014

TodayJul 2026

First PostedApr 30, 2014

Enrollment StartJun 1, 2005

Primary CompletionJun 1, 2006

TodayJul 2, 2026

Enrollment to primary: 1 yearPosted 12.2 years ago

Interventions

1 mL/kg bupivacaine 0.25%.drug

40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia. Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5mL 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.