Postoperative Analgesia
Conditions
Keywords
Pediatrics, ketamine, postoperative analgesia, nalbuphine, 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.
Interventions
DRUGketamine
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the curve of pain scores (CHEOPS) measured | every 2 hours during the first 24 hours after eyes open |
Secondary
| Measure | Time frame |
|---|---|
| Number of painful episodes requiring additional boluses of nalbuphine | — |
| Number of children requiring morphine after inefficiency of additional boluses of nalbuphine | — |
| 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 |
| Time to complete feeding | — |
| Percentage of children with nausea or vomiting | — |
| Percentage of children with side effects related to injection of ketamine | — |
Countries
France
Contacts
Primary ContactVéronique Bazin, MD
Outcome results
None listed