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

Primary Purpose

Analgesia

Status
Unknown status
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
S(+)-ketamine
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring Epidural, Intravenous, Ketamine, Analgesia, Caudal, Pediatric, Regional, Local Anesthetics

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • orthopedic ward of Imam Khomeini hospitalRecruiting
  • orthopedic surgery room- Imam Khomeini hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

epidural s(+)-ketamine for supplementation of caudal anesthesia

intravenous ketamine for supplementation of caudal anesthesia

Outcomes

Primary Outcome Measures

pain score

Secondary Outcome Measures

analgesic request

Full Information

First Posted
September 19, 2007
Last Updated
November 17, 2010
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00532662
Brief Title
Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery
Official Title
Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Epidural, Intravenous, Ketamine, Analgesia, Caudal, Pediatric, Regional, Local Anesthetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
epidural s(+)-ketamine for supplementation of caudal anesthesia
Arm Title
2
Arm Type
Active Comparator
Arm Description
intravenous ketamine for supplementation of caudal anesthesia
Intervention Type
Drug
Intervention Name(s)
S(+)-ketamine
Intervention Description
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
Primary Outcome Measure Information:
Title
pain score
Time Frame
24 hours after anesthesia
Secondary Outcome Measure Information:
Title
analgesic request
Time Frame
24 hours after anesthesia

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamid Reza Amiri, MD
Phone
021-61192628
Email
hramiri@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ramin Espandar, MD
Organizational Affiliation
Imam Khomeini hospital- tehran university of medical sciences
Official's Role
Study Chair
Facility Information:
Facility Name
orthopedic ward of Imam Khomeini hospital
City
Tehran
ZIP/Postal Code
1419733141
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ramin Espandar, MD
Phone
02161192627
Email
espandarmd@sina.tums.ac.ir
Facility Name
orthopedic surgery room- Imam Khomeini hospital
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siamak Yousef Sibdari, MD
Phone
021-61192627
Email
sibdari@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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