NCT00200564

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

October 23, 2007

Status Verified

July 1, 2005

First QC Date

September 12, 2005

Last Update Submit

October 22, 2007

Conditions

Postoperative Analgesia

Keywords

Pediatricsketaminepostoperative analgesianalbuphinePostoperative analgesia in children

Outcome Measures

Primary Outcomes (1)

  • Area under the curve of pain scores (CHEOPS) measured

    every 2 hours during the first 24 hours after eyes open

Secondary Outcomes (6)

  • 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

  • Number of children requiring morphine after inefficiency of additional boluses of nalbuphine

  • Percentage of children with side effects related to injection of ketamine

  • Time to complete feeding

  • +1 more secondary outcomes

Interventions

ketamineDRUG

Eligibility Criteria

Age6 Months - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

RECRUITING

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

CyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Véronique Bazin, MD

    Nantes UH

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Bazin, MD

CONTACT

00 33 2 40 08 35 47veronique.bazin@chu-nantes.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Last Updated

October 23, 2007

Record last verified: 2005-07

Locations

FR(1)