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Completed

NCT Number: NCT02127489

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

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.

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Key information

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: AstraZeneca Marcaine

Primary outcomes

  1. Sedation scale and postoperative pain scale (CHIPPS)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Apr 30, 2014
Registry last updated
Apr 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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