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Paracetamol and antiemetic drugs in Pain management

Paracetamol and setrons : drug interactions in the management of pain after tonsillectomy in children - PARATRON

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-002213-12-FR
Enrollment
Unknown
Registered
2011-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain MedDRA version: 14.0 Level: LLT Classification code 10049749 Term: Post procedural pain System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.0 Level: PT Classification code 10064882 Term: Procedural pain System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: Paracetamol Panpharma Pharmaceutical Form: Solution for injection INN or Proposed INN: PARACETAMOL CAS Number: 103-90-2 Trade Name: ONDASETRON MYLAN Pharmaceutical Form: Solution for inje

Sponsors

CHU de Limoges
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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) - 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

MeasureTime frame
Timepoint(s) of evaluation of this end point: In the first 24 hours;Secondary end point(s): - analgesic consumption - incidence of nausea and vomiting.—

Countries

France

Contacts

Public ContactPrincipal Investigator

CHU Limoges

nathan@unilim.fr05 55 05 67 83

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026