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

Phase 4

• Conditions: Analgesia
• Interventions: Drug: S(+)-ketamine

• Registration Number: NCT00532662
• Lead Sponsor: Tehran University of Medical Sciences

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-09-19
• Study First Submitted QC: 2007-09-19
• Study First Posted: 2007-09-20
• Study Start: 2007-11
• Primary Completion: 2009-06
• Study Completion: 2009-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-17
• Last Update Posted: 2010-11-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Children aged < = 12 years
• Children scheduled for elective orthopedic surgery with caudal block
• ASA score < = 3

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	S(+)-ketamine	epidural s(+)-ketamine for supplementation of caudal anesthesia
2	S(+)-ketamine	intravenous ketamine for supplementation of caudal anesthesia

Primary Outcome Measures

Name	Time	Method
pain score	24 hours after anesthesia

Secondary Outcome Measures

Name	Time	Method
analgesic request	24 hours after anesthesia

Trial Locations

Locations (2)

orthopedic ward of Imam Khomeini hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

orthopedic surgery room- Imam Khomeini hospital; 🇮🇷 Tehran, Iran, Islamic Republic of