Maxi-Analgesic Junior Study:A multi-centre prospective, parallel group, double-blind, randomized comparison of the analgesic effect of a combination of paracetamol and ibuprofen with paracetamol alone or ibuprofen alone in post tonsillectomy patients

AFT Pharmaceuticals New Zealand0 个研究点目标入组 150 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•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.

•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.

发起方

AFT Pharmaceuticals New Zealand