Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery
Brief Summary
Preemptive analgesia can improve postoperative pain management. Ketamine may prevent central sensitization during surgery and result in preemptive analgesia. The purpose of this study is to examine the effectiveness of ketamine as a preemptive analgesic as previous studies have shown the involvement of N-methyl-D-Aspartate (NMDA) receptor in neuroplasticity.
Intervention / Treatment
-
S(+)-ketamine (DRUG)epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
Condition or Disease
- Analgesia
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Unknown status |
| Study results: | No Results Available |
| Age: | up to 12 Years (Child) |
| Enrollment: | 40 (ESTIMATED) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Nov 01, 2007 | |
|---|---|---|
| Primary Completion: | Jun 01, 2009 | ESTIMATED |
| Completion Date: | Jul 01, 2009 | ESTIMATED |
| Study First Posted: | Sep 20, 2007 | ESTIMATED |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Nov 17, 2010 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
After receiving consent inform from parents, 40 children scheduled for orthopedic surgeries will be randomized to one of two groups: epidural group and intravenous group, both will receive 1 mg kg-1 S(+)-ketamine. All patients will receive caudal block anesthesia with marcaine. Cardiovascular monitoring will be assessed during operation. Follow up will continue for 24 hours after caudal block. Duration of analgesia, first time of analgesic request and complications will be recorded by an orthopedic assistant that is blinded to study. Data will be analyzed statistically by Chi square, t test and nonparametric tests.
Eligibility Criteria
| Sex: | All |
|---|---|
| Maximum Age: | 12 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Children aged \< = 12 years
* Children scheduled for elective orthopedic surgery with caudal block
* ASA score \< = 3
Exclusion Criteria:
* Contraindication for caudal block such as vertebral defect or infection at the site of block
* Disagreement of parents
* Patient's age \> 12 years
* ASA score \> = 4
* Children aged \< = 12 years
* Children scheduled for elective orthopedic surgery with caudal block
* ASA score \< = 3
Exclusion Criteria:
* Contraindication for caudal block such as vertebral defect or infection at the site of block
* Disagreement of parents
* Patient's age \> 12 years
* ASA score \> = 4
Primary Outcomes
-
pain score 24 hours after anesthesia
Secondary Outcomes
-
analgesic request 24 hours after anesthesia
More Details
| NCT Number: | NCT00532662 |
|---|---|
| Other IDs: | 86-02-78-56790 |
| Study URL: | https://clinicaltrials.gov/study/NCT00532662 |
Last updated: Sep 29, 2023