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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00532662
• Other study ID #: 86-02-78-56790
• Status: Recruiting
• Phase: Phase 4
• First received: September 19, 2007
• Last updated: November 17, 2010
• Start date: November 2007
• Est. completion date: July 2009

Study information

• Verified date: November 2010
• Source: Tehran University of Medical Sciences
• Contact: Hamid Reza Amiri, MD
• Phone: 021-61192628
• Email: hramiri[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

Locations

Country	Name	City	State
Iran, Islamic Republic of	orthopedic surgery room- Imam Khomeini hospital	Tehran
Iran, Islamic Republic of	orthopedic ward of Imam Khomeini hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain score		24 hours after anesthesia	No
Secondary	analgesic request		24 hours after anesthesia	No