Trial | NCT02127489  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
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 Started
Jun 30
2005
Primary Completion
Jun 30
2006
Study Completion
Jun 30
2006
Last Update
Apr 30
2014
Estimate

Drug 1 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.

  • Other names: AstraZeneca Marcaine

Midazolam Active Comparator

1 mL/kg bupivacaine 0.25%.

saline Placebo Comparator

5mL rectal saline

Criteria 

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
No Results Posted