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

Karadeniz Technical University

Status and phase: Completed; Phase 4

Conditions: Failed Moderate Sedation During Procedure

Treatments: Drug: 1 mL/kg bupivacaine 0.25%.

Study type: Interventional

Funder types: Other

Identifiers

NCT02127489

B.30.2.KTU.0.01.00.01/372

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Midazolam

Active Comparator group

Description:

1 mL/kg bupivacaine 0.25%.

Treatment:

Drug: 1 mL/kg bupivacaine 0.25%.

saline

Placebo Comparator group

Description:

5mL rectal saline

Treatment:

Drug: 1 mL/kg bupivacaine 0.25%.