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
Recruitment status was Recruiting
Sponsor:
Tehran University of Medical Sciences
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
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 Anesthetics, Dissociative Anesthetics, Intravenous |
Anesthetics, General Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013