Health Condition 1: null- In Post opertaive tonsillectomy
Conditions
Interventions
Intervention1: Paracetamol 120mg + ibuprofen 60mg per 5ml (Maxigesic Junior): 0.5 ml/kg every 6 hours orally, with food
Control Intervention1: Paracetamol 120mg/5ml 0.5 ml/kg
Ibuprofen 60mg/5ml 0.5
Sponsors
AFT Pharmaceuticals New Zealand
Eligibility
Inclusion criteria
Inclusion criteria: Present to study centre for routine tonsillectomy, under the care of a participating surgeon. Be between 6-14 years of age on the day of consent. Provide written informed consent before initiation of any study-related procedures from a parent or legal guardian and, where appropriate, written assent themselves. We acknowledge that some children are able to provide consent, but will not recruit any subject unless both the patient and his or her parent or legal guardian are willing for this to occur and the parent or legal guardian must still provide his/her own consent.
Exclusion criteria
Exclusion criteria: Patients will be excluded from the study if any of the following exclusion criteria apply prior to randomization: Study contra-indications ? Patient declines assent (or consent) or parent declines consent. ? Too young (<6 years) or too old (>14 years). ? Too small (weight below 15kg at base line visit). ? Having taken any NSAID or paracetamol within 12 hours prior to the operation. ? Known to be pregnant or possibly pregnant. ? Suffering from a neurological disorder relating to pain perception. ? In the opinion of the study staff, unable to understand the visual analogue pain score. ? Currently or in last 30 days, having participated in a clinical trial involving another study drug. ? Suffering from any other diseases or condition which, in the opinion of the investigator, means that it would not be in the patient?s best interests to participate in this study. NSAID and/or paracetamol contra-indications ? Hypersensitivity to aspirin or other NSAID. ? Hypersensitivity to paracetamol. ? Severe known haemopoetic, renal or hepatic disease, immunosuppressant. ? History of gastric ulceration, indigestion, stomach pain or bleeding. ? Currently suffering from dehydration through diarrhoea and/or vomiting. ? History of severe asthma defined as previous steroid treatment or hospital admission.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective in this trial is to compare the effects of the 3 treatment groups (paracetamol + ibuprofen, paracetamol and ibuprofen) on the time adjusted area under the curve (AUCt) of the visual analogue scale (VAS) pain scores (taken at rest) from the first dose of study medication until one hour after the last dose of study medication (i.e. for up to 48 hours).Timepoint: From the first dose of study medication until one hour after the last dose of study medication (i.e. for up to 48 hours) | — |
Secondary
| Measure | Time frame |
|---|---|
| AUCt of the VAS pain scores from the first dose of study medication until 30-60 mins after the last dose of study medication (i.e. up to 48 hours)Rating of sleep disturbance attributable to pain on a 100mm VAS for the first and second post operative night (assisted by the parents or guardian as required)Requirement for rescue analgesia during recovery room and after discharge from recovery room Categorical global pain rating over the study periodTimepoint: Nil | — |
Countries
India, New Zealand
Contacts
Public ContactMr. Piyush Pandya
Outcome results
None listed