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

NCT ID: NCT00532662

Last Updated: 2010-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-07-31

Brief Summary

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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

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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.

Conditions

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Analgesia

Keywords

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Epidural Intravenous Ketamine Analgesia Caudal Pediatric Regional Local Anesthetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

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

Group Type EXPERIMENTAL

S(+)-ketamine

Intervention Type DRUG

epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

2

intravenous ketamine for supplementation of caudal anesthesia

Group Type ACTIVE_COMPARATOR

S(+)-ketamine

Intervention Type DRUG

epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

Interventions

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S(+)-ketamine

epidural or intravenous 1 mg kg-1 once concurrent with caudal anesthesia

Intervention Type DRUG

Eligibility Criteria

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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
Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tehran University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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TehranUMS

Principal Investigators

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Ramin Espandar, MD

Role: STUDY_CHAIR

Imam Khomeini hospital- tehran university of medical sciences

Locations

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orthopedic ward of Imam Khomeini hospital

Tehran, Tehran Province, Iran

Site Status RECRUITING

orthopedic surgery room- Imam Khomeini hospital

Tehran, Tehran Province, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Hamid Reza Amiri, MD

Role: CONTACT

Phone: 021-61192628

Email: [email protected]

Facility Contacts

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Ramin Espandar, MD

Role: primary

Siamak Yousef Sibdari, MD

Role: primary

Other Identifiers

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86-02-78-56790

Identifier Type: -

Identifier Source: org_study_id