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

NCT02127489 | Completed Phase 4

• 1 other identifier: B.30.2.KTU.0.01.00.01/372
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Failed Moderate Sedation During Procedure

Keywords

Bupivacaine, caudal, rectal midazolam, children

Outcome Measures

Primary Outcomes (1)

• Sedation scale and postoperative pain scale (CHIPPS)

  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.

  24 hours

Study Arms (2)

Midazolam

ACTIVE COMPARATOR

1 mL/kg bupivacaine 0.25%.

Drug: 1 mL/kg bupivacaine 0.25%.

saline

PLACEBO COMPARATOR

5mL rectal saline

Drug: 1 mL/kg bupivacaine 0.25%.

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.

Also known as: AstraZeneca Marcaine

Midazolam; saline

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• children having lower abdominal surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead

Study Sites (1)

Karadeniz Technical University Faculty of Medicine

Trabzon, 61080, Turkey (Türkiye)

Location

Related Publications (21)

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• Saylan S, Eroglu A, Dohman D. The effects of single-dose rectal midazolam application on postoperative recovery, sedation, and analgesia in children given caudal anesthesia plus bupivacaine. Biomed Res Int. 2014;2014:127548. doi: 10.1155/2014/127548. Epub 2014 May 5.

  PMID: 24883300 DERIVED

Related Links

• U.S. National Library of Medicine

Study Officials

• SEDAT SAYLAN, Med. doctor

  KANUNI EDUCATION AND RESEARCH HOSPITAL, TRABZON ,TURKEY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 18, 2014
• First Posted: April 30, 2014
• Study Start: June 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: April 30, 2014

Record last verified: 2014-04

Locations

TU (1)