NCT01432977

Brief Summary

The aim of this study is to demonstrate that the association paracetamol / ondansetron is not as effective as the association paracetamol / droperidol in the treatment of pain in children following tonsillectomy. The secondary objectives are to compare opioid consumption (morphine / codeine) and the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_3 pain

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 31, 2012

Status Verified

October 1, 2012

Enrollment Period

9 months

First QC Date

September 9, 2011

Last Update Submit

October 30, 2012

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • -pain scores

    pain scores at rest 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively

    4 hours after drug administration

Secondary Outcomes (2)

  • analgesic consumption

    24 hours after inclusion

  • incidence of nausea and vomiting.

    data continuiousley collected during 24 hours

Study Arms (2)

comparateur

ACTIVE COMPARATOR

paracetamol / droperidol

Drug: paracetamol /droperidol

Eperimental

EXPERIMENTAL

paracetamol / ondansetron

Drug: paracetamol / ondansetron

Interventions

paracetamol /droperidolDRUG
comparateur
paracetamol / ondansetronDRUG
Eperimental

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • tonsillectomy in a child 2-7 years old who is hospitalized for at least 24 hours ;
  • informed consent from one parent at least

You may not qualify if:

  • hospital stay of less than 24 hours ;
  • patient already on pain medication ;
  • allergic patient with a contra-indication to one of the study drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Chirurgie Ped

Limoges, 87042, France

Location

Service Anesthésie

Limoges, 87042, France

Location

MeSH Terms

Conditions

Pain

Interventions

AcetaminophenDroperidolOndansetron

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesButyrophenonesKetonesBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsImidazolesAzolesHeterocyclic Compounds, 1-RingCarbazolesIndolesHeterocyclic Compounds, 3-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2011

First Posted

September 13, 2011

Study Start

September 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 31, 2012

Record last verified: 2012-10

Locations

FR(2)