Paracetamol and antiemetic drugs in Pain management

Phase 1

• Conditions: Pain; MedDRA version: 14.0Level: LLTClassification code 10049749Term: Post procedural painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.0Level: PTClassification code 10064882Term: Procedural painSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002213-12-FR
• Lead Sponsor: CHU de Limoges

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-17
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- tonsillectomy in a child 2-7 years old
- informed consent from parents
Are the trial subjects under 18? yes
Number of subjects for this age range: 70
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- hospital stay of less than 24 hours ;
- patient already on pain medication ;
- allergic patient to one of the study drugs

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main objectif 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. ;Secondary Objective: - to compare opioid consumption (morphine / codeine) <br>- the cumulated incidence of nausea and vomiting between the two groups of patients in the first 24 hours after surgery. ;Primary end point(s): pain scores at rest ;Timepoint(s) of evaluation of this end point: 4 hours after administration of paracetamol and ondansetron / droperidol intraoperatively.

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: In the first 24 hours;Secondary end point(s): - analgesic consumption <br>- incidence of nausea and vomiting. <br>