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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Tehran University of Medical Sciences.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00532662
First received: September 19, 2007
Last updated: November 17, 2010
Last verified: November 2010
  Purpose

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.


Condition Intervention Phase
Analgesia
Drug: S(+)-ketamine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-blind Controlled Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • pain score [ Time Frame: 24 hours after anesthesia ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • analgesic request [ Time Frame: 24 hours after anesthesia ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
epidural s(+)-ketamine for supplementation of caudal anesthesia
Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
Active Comparator: 2
intravenous ketamine for supplementation of caudal anesthesia
Drug: S(+)-ketamine
epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

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.

  Eligibility

Ages Eligible for Study:   up to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532662

Contacts
Contact: Hamid Reza Amiri, MD 021-61192628 hramiri@gmail.com

Locations
Iran, Islamic Republic of
orthopedic surgery room- Imam Khomeini hospital Recruiting
Tehran, Iran, Islamic Republic of
Contact: Siamak Yousef Sibdari, MD    021-61192627    sibdari@gmail.com   
orthopedic ward of Imam Khomeini hospital Recruiting
Tehran, Iran, Islamic Republic of, 1419733141
Contact: Ramin Espandar, MD    02161192627    espandarmd@sina.tums.ac.ir   
Sponsors and Collaborators
Tehran University of Medical Sciences
Investigators
Study Chair: Ramin Espandar, MD Imam Khomeini hospital- tehran university of medical sciences
  More Information

No publications provided

Responsible Party: HamidReza Amiri/Assistant professor, TehranUMS
ClinicalTrials.gov Identifier: NCT00532662     History of Changes
Other Study ID Numbers: 86-02-78-56790
Study First Received: September 19, 2007
Last Updated: November 17, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
Epidural
Intravenous
Ketamine
Analgesia
Caudal
Pediatric
Regional
Local Anesthetics

Additional relevant MeSH terms:
Anesthetics
Ketamine
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 27, 2014