Postoperative Analgesia by Epidural vs IV Ketamine Concurrent With Caudal Anesthesia in Pediatric Orthopedic Surgery - Full Text View

Sponsored by:	Tehran University of Medical Sciences
Information provided by:	Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00532662

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 IV

MedlinePlus related topics: Anesthesia Surgery

Drug Information available for: Ketamine hydrochloride Ketamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Intravenous Versus Caudal Supplementation of Ketamine for Postoperative Pain Control in Children,A Double-Blind Controlled Clinical Trial.

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
1: Experimental epidural s(+)-ketamine for supplementation of caudal anesthesia	Drug: S(+)-ketamine epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia
2: Active Comparator 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

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:	TehranUMS ( HamidReza Amiri/Assistant professor )
Study ID Numbers:	86-02-78-56790
Study First Received:	September 19, 2007
Last Updated:	May 2, 2009
ClinicalTrials.gov Identifier:	NCT00532662 History of Changes
Health Authority:	Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:

Epidural
Intravenous
Ketamine
Analgesia

Caudal
Pediatric
Regional
Local Anesthetics

Study placed in the following topic categories:

Anesthetics, Intravenous
Excitatory Amino Acids
Neurotransmitter Agents
Anesthetics
Central Nervous System Depressants
Pain
Anesthetics, Local

Anesthetics, Dissociative
Anesthetics, General
Ketamine
Analgesics
Peripheral Nervous System Agents
Pain, Postoperative

Additional relevant MeSH terms:

Anesthetics, Intravenous
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Agents
Anesthetics, Dissociative
Pharmacologic Actions

Sensory System Agents
Anesthetics, General
Therapeutic Uses
Ketamine
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 07, 2009