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Ketamine and Postoperative Analgesia in Children

NCT ID: NCT00200564

Last Updated: 2007-10-23

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

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Brief Summary

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The benefit of small doses of ketamine has been demonstrated for postoperative analgesia in adults but remains unproved in children. The investigators' purpose is to evaluate the effects of continuous intravenous small doses of ketamine versus placebo to improve the quality of postoperative analgesia in children (6 months to 6 years of age). Caudal anesthesia is performed for intraoperative analgesia and all children receive paracetamol, a non-steroidal anti-inflammatory and continuous intravenous nalbuphine.

Detailed Description

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Conditions

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Postoperative Analgesia

Keywords

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Pediatrics ketamine postoperative analgesia nalbuphine Postoperative analgesia in children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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ketamine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Children between 6 months to 6 years of age
* American Society of Anesthesiologists (ASA) I or II
* Undergoing elective surgery with intraoperative caudal analgesia

Exclusion Criteria

* ASA III or IV
* Contraindication to caudal anesthesia
* Allergy to drugs used in the study
* Failure in caudal puncture
* Administration of morphine derivative
Minimum Eligible Age

6 Months

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Véronique Bazin, MD

Role: PRINCIPAL_INVESTIGATOR

Nantes UH

Locations

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Nantes University Hospital

Nantes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Véronique Bazin, MD

Role: CONTACT

Phone: 00 33 2 40 08 35 47

Email: [email protected]

Facility Contacts

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Véronique Bazin, MD

Role: primary

Other Identifiers

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BRD/03/12-H

Identifier Type: -

Identifier Source: org_study_id