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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02127489
Enrollment
40
Registered
2014-04-30
Start date
2005-06-30
Completion date
2006-06-30
Last updated
2014-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Moderate Sedation During Procedure

Keywords

Bupivacaine, caudal, rectal midazolam, children

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.

Interventions

DRUG1 mL/kg bupivacaine 0.25%.

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.

Sponsors

Karadeniz Technical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
2 Years to 10 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sedation scale and postoperative pain scale (CHIPPS)24 hoursSedation 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026