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Ketamine and Postoperative Analgesia in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Nantes University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00200564
First received: September 12, 2005
Last updated: October 22, 2007
Last verified: July 2005
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Official Title: Ketamine and Postoperative Analgesia in Children

Resource links provided by NLM:

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

ClinicalTrials.gov Identifier: NCT00200564     History of Changes
Other Study ID Numbers: BRD/03/12-H
Study First Received: September 12, 2005
Last Updated: October 22, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Nantes University Hospital:
Pediatrics
ketamine
postoperative analgesia
nalbuphine
Postoperative analgesia in children

Additional relevant MeSH terms:
Ketamine
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
 Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013