Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery

November 17, 2010 updated by: Tehran University of Medical Sciences

Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.

Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of, 1419733141
        • Recruiting
        • orthopedic ward of Imam Khomeini hospital
        • Contact:
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • orthopedic surgery room- Imam Khomeini hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children aged < = 12 years
  • Children scheduled for elective orthopedic surgery with caudal block
  • ASA score < = 3

Exclusion Criteria:

  • Contraindication for caudal block such as vertebral defect or infection at the site of block
  • Disagreement of parents
  • Patient's age > 12 years
  • ASA score > = 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
epidural s(+)-ketamine for supplementation of caudal anesthesia
Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
Active Comparator: 2
intravenous ketamine for supplementation of caudal anesthesia
Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
pain score
Time Frame: 24 hours after anesthesia
24 hours after anesthesia

Secondary Outcome Measures

Outcome Measure
Time Frame
analgesic request
Time Frame: 24 hours after anesthesia
24 hours after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Investigators

  • Study Chair: Ramin Espandar, MD, Imam Khomeini Hospital- Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2007

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

September 19, 2007

First Submitted That Met QC Criteria

September 19, 2007

First Posted (Estimate)

September 20, 2007

Study Record Updates

Last Update Posted (Estimate)

November 18, 2010

Last Update Submitted That Met QC Criteria

November 17, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86-02-78-56790

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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