Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.

Conditions
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Analgesia

Intervention / Treatment
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* Drug: S(+)-ketamine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>epidural s(+)-ketamine for supplementation of caudal anesthesia | Drug: S(+)-ketamine<br>* epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia<br>|
| Active Comparator: 2<br>intravenous ketamine for supplementation of caudal anesthesia | Drug: S(+)-ketamine<br>* epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score |  | 24 hours after anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analgesic request |  | 24 hours after anesthesia | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural, Intravenous, Ketamine, Analgesia, Caudal, Pediatric, Regional, Local Anesthetics