Ketamine and Postoperative Analgesia in Children

This study is currently recruiting participants.

Verified by Nantes University Hospital, July 2005

First Received: September 12, 2005 Last Updated: October 22, 2007 History of Changes

Sponsor:	Nantes University Hospital
Information provided by:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT00200564

Purpose

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.

Condition	Intervention	Phase
Postoperative Analgesia	Drug: ketamine	Phase IV

Study Type:	Interventional
Study Design:	Randomized, Single Blind, Placebo Control, Parallel Assignment
Official Title:	Ketamine and Postoperative Analgesia in Children

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	74
Study Start Date:	February 2004

Eligibility

Ages Eligible for Study:	6 Months to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00200564

Contacts

Contact: Véronique Bazin, MD

00 33 2 40 08 35 47

veronique.bazin@chu-nantes.fr

Locations

France
Nantes University Hospital	Recruiting
Nantes, France, 44093
Contact: Véronique Bazin, MD 00 33 2 40 08 35 47 veronique.bazin@chu-nantes.fr

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:

Véronique Bazin, MD

Nantes UH

More Information

No publications provided

Study ID Numbers:	BRD/03/12-H
Study First Received:	September 12, 2005
Last Updated:	October 22, 2007
ClinicalTrials.gov Identifier:	NCT00200564 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Nantes University Hospital:

Pediatrics
ketamine
postoperative analgesia
nalbuphine
Postoperative analgesia in children

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Ketamine
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on November 11, 2009