ISRCTN84216266已完成未知
A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on post-operative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment
Gwent Healthcare NHS Trust (UK)0 个研究点目标入组 68 人开始时间: 2009年1月23日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 12 to 16 years, either sex
- •2. Requiring surgery necessitating the raising of a mucoperiosteal flap and bone removal in at least one but not more than two sites
- •3. Suitable for ambulatory surgery
排除标准
- •1. Age under 12 years
- •2. History of allergy to local anaesthetic of the amide type or to any components of the injectable formulation, paracetamol or non-steroidal anti-inflammatory drugs
- •Exclusion criteria due to the presence of adrenaline in the local anaesthetic formula:
- •3. Arterial hypertension
- •4. Coronary disease
- •5. Valvular heart disease
- •Standard anaesthetic-based exclusions for ambulatory surgery:
- •6. American Society of Anaesthesiologists (ASA) grade greater than 2
- •7. Body mass index greater than 35
- •8. Poorly controlled asthma
研究者
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A double blind randomised placebo controlled study assessing the effect of intra-operative local anaesthetic administration on postoperative pain in adolescent children undergoing oral surgery under general anaesthetic to facilitate orthodontic treatment.Postoperative pain following oral surgery in 12 to 16 year oldsMedDRA version: 9.1Level: LLTClassification code 10024759Term: Local anaestheticMedDRA version: 9.1Level: LLTClassification code 10054711Term: Postoperative painEUCTR2008-000254-13-GBGwent Healthcare NHS Trust
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