Ketamine and Postoperative Analgesia in Children
Phase 4
- Conditions
- Postoperative Analgesia
- Registration Number
- NCT00200564
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 74
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Area under the curve of pain scores (CHEOPS) measured every 2 hours during the first 24 hours after eyes open
- Secondary Outcome Measures
Name Time Method Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10 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
Trial Locations
- Locations (1)
Nantes University Hospital
🇫🇷Nantes, France