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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

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date October 23, 2007
Study Start Date  ICMJE February 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 22, 2007)
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
 (submitted: September 12, 2005)
Area under the curve of pain scores (CHEOPS) measured every 2 hours during the first 24 hours after eyes opening.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2007)
  • 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
 (submitted: September 12, 2005)
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Condition  ICMJE Postoperative Analgesia
Intervention  ICMJE Drug: ketamine
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 12, 2005)
74
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Months to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00200564
Other Study ID Numbers  ICMJE BRD/03/12-H
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Nantes University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Véronique Bazin, MD Nantes UH
PRS Account 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