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Ketamine and Postoperative Analgesia in Children

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ClinicalTrials.gov Identifier: NCT00200564
Recruitment Status : Unknown
Verified July 2005 by Nantes University Hospital.
Recruitment status was:  Recruiting
First Posted : September 20, 2005
Last Update Posted : October 23, 2007
Sponsor:
Information provided by:
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Postoperative Analgesia Drug: ketamine Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Official Title: Ketamine and Postoperative Analgesia in Children
Study Start Date : February 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine




Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. Number of painful episodes requiring additional boluses of nalbuphine
  3. Number of children requiring morphine after inefficiency of additional boluses of nalbuphine
  4. Percentage of children with side effects related to injection of ketamine
  5. Time to complete feeding
  6. Percentage of children with nausea or vomiting


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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00200564     History of Changes
Other Study ID Numbers: BRD/03/12-H
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: July 2005

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

Additional relevant MeSH terms:
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action