Ketamine and Postoperative Analgesia in Children
Information source: Nantes University Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Analgesia
Intervention: ketamine (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Nantes University Hospital Official(s) and/or principal investigator(s):
Véronique Bazin, MD, Principal Investigator, Affiliation: Nantes UH
Overall contact:
Véronique Bazin, MD, Phone: 00 33 2 40 08 35 47, Email: veronique.bazin@chu-nantes.fr
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.
Clinical Details
Official title: Ketamine and Postoperative Analgesia in Children
Study design: Randomized, Single Blind, Placebo Control, Parallel Assignment
Primary outcome: Area under the curve of pain scores (CHEOPS) measured
Secondary outcome: Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10Number 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
Eligibility
Minimum age: 6 Months.
Maximum age: 6 Years.
Gender(s): Both.
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
Locations and Contacts
Véronique Bazin, MD, Phone: 00 33 2 40 08 35 47, Email: veronique.bazin@chu-nantes.fr
Nantes University Hospital, Nantes 44093, France; Recruiting
Véronique Bazin, MD, Phone: 00 33 2 40 08 35 47, Email: veronique.bazin@chu-nantes.fr
Additional Information
Starting date: February 2004
Last updated: October 22, 2007
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