ACTRN12615000456550已完成2 期
A randomized, single-blind, parallel group, comparison of the pharmacokinetic profiles, dose response, analgesic effectiveness and safety of high and low dose of a paracetamol and ibuprofen fixed dose combination in children undergoing tonsillectomy with or without adenoidectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 253
研究概览
简要总结
This fixed dose combination (paracetamol 32 mg/mL + ibuprofen 9.6 mg/mL oral suspension) is safe to provide comparable pain relief at two different dose regimen ((Higher dose: paracetamol 15 mg/kg + ibuprofen 4.5 mg/kg, Lower dose: paracetamol 12 mg/kg + ibuprofen 3.6 mg/kg) among children aged from 2-12 years old following their tonsillectomy surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 2 Years 至 12 Years(—)
- 性别
- All
入选标准
- •Children aged 2-12 yrs of age
- •Scheduled to undergo tonsillectomy with or without adenoidectomy
- •Written informed consent from parents/legal guardians and assent from participant (where appropriate).
排除标准
- •Participants declines assent (or consent) or parent declines consent
- •Two small (weight<10kg at baseline)
- •Having taken any NSAID or paracetamol within 12hrs prior to the surgery
研究者
相似试验
已完成
3 期
Ibuprofen/Acetaminophen Versus Nurofen Plus® and Panadeine® Extra Dental Pain StudyPost-operative PainNCT01229449Reckitt Benckiser LLC678
已完成
4 期
Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back PainLow Back PainNCT05222724Aziende Chimiche Riunite Angelini Francesco S.p.A176
已完成
3 期
Efficacy and Safety of Paracetamol, Chlorpheniramine and Phenylephrine in the Treatment of Common Cold and Flu SyndromeFluNCT01389518Hospital de Clinicas de Porto Alegre146
招募中
4 期
Paracetamol or Ibuprofen in the Primary Prevention of Asthma in Tamariki (PIPPA Tamariki).BronchiolitisAsthmaACTRN12618000303246Auckland District Health Board3,922
已完成
4 期
Comparison of the Efficacy of Paracetamol and Ibuprofen in the Management of Fever in Sepsis PatientsAcetaminophenFeverIbuprofenSepsisNCT06061575Ankara City Hospital Bilkent113
