Ketamine and Postoperative Analgesia in Children | NCT00200564

Studies
Ketamine and Postoperative Analgesia in Children

NCT00200564

Sponsor

Nantes University Hospital

Status

Unknown status

Last Update Posted

Oct 23, 2007Estimated

Enrollment

74Estimated

Phase

Phase 4

Conditions

Postoperative Analgesia

Interventions

ketamine

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2007

Last Update Posted Date

Oct 23, 2007Estimated

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Estimated

Name	Type	Description	Arm Group Labels	Other Names
ketamine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve of pain scores (CHEOPS) measured		every 2 hours during the first 24 hours after eyes open

Secondary Outcomes

Measure	Description	Time Frame
Evaluation by the parents and nurses of the quality of analgesia with a visual analogue scale graded from 0 to 10		at the 24th hour
Number of painful episodes requiring additional boluses of nalbuphine

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Véronique Bazin, MD	Contact	00 33 2 40 08 35 47		veronique.bazin@chu-nantes.fr

Overall Officials

Name	Affiliation	Role
Véronique Bazin, MD	Nantes UH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nantes University Hospital	Recruiting	Nantes		44093	France

Intervention Browse Module

MeSH Terms

ID	Term
D007649	Ketamine

Ancestor Terms

ID	Term
D003510	Cyclohexanes
D003516	Cycloparaffins
D006840	Hydrocarbons, Alicyclic
D006844	Hydrocarbons, Cyclic

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