Ketamine and Postoperative Analgesia in Children - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

October 22, 2007

Start Date ^ICMJE

February 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Area under the curve of pain scores (CHEOPS) measured [ Time Frame: every 2 hours during the first 24 hours after eyes open ]

Original Primary Outcome Measures ^ICMJE

Area under the curve of pain scores (CHEOPS) measured every 2 hours during the first 24 hours after eyes opening.

Change History

Complete list of historical versions of study NCT00200564 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10 [ Time Frame: at the 24th hour ]
Number of painful episodes requiring additional boluses of nalbuphine
Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
Percentage of children with side effects related to injection of ketamine
Time to complete feeding
Percentage of children with nausea or vomiting

Original Secondary Outcome Measures ^ICMJE

Evaluation by the parents and nurses at the 24th hour of the quality of analgesia with a visual analogue scale graded from 0 to 10.
Number of painful episode requiring addition boluses of nalbuphine
Number of children requiring morphine after inefficiency of additional boluses of nalbuphinePercentage of children with nausea or vomiting
Percentage of chidren with side effects related to injection of ketamine
Time to complete feeding

Descriptive Information

Brief Title ^ICMJE

Ketamine and Postoperative Analgesia in Children

Official Title ^ICMJE

Ketamine and Postoperative Analgesia in Children

Brief Summary

The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Randomized, Single Blind, Placebo Control, Parallel Assignment

Condition ^ICMJE

Postoperative Analgesia

Intervention ^ICMJE

Drug: ketamine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children between 6 months to 6 years of age
American Society of Anesthesiologists (ASA) I or II
Undergoing elective surgery with intraoperative caudal analgesia

Exclusion Criteria:

ASA III or IV
Contraindication to caudal anesthesia
Allergy to drugs used in the study
Failure in caudal puncture
Administration of morphine derivative

Gender

Both

Ages

6 Months to 6 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Véronique Bazin, MD

00 33 2 40 08 35 47

veronique.bazin@chu-nantes.fr

Location Countries ^ICMJE

France

Administrative Information

NCT ID ^ICMJE

NCT00200564

Responsible Party

Study ID Numbers ^ICMJE

BRD/03/12-H

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Véronique Bazin, MD

Nantes UH

Information Provided By

Nantes University Hospital

Verification Date

July 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP