ISRCTN13661311已完成未知
Intranasal fentanyl combined with oral midazolam for pediatric dental sedation: a controlled randomized blinded cross-over clinical trial
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 32
研究概览
简要总结
2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35204863/ Post-discharge effects and parents' opinions (added 15/07/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. 3 - 6 years old
- •3. Frankl behaviour rating scale 1 or 2
- •4. Mallampati score I or II
- •5. Brodsky tonsillar size scoring 0 or 1 or 2
- •6. Children within the normal range of weight
- •7. Children who needed two sedation visits for completion of dental treatment
- •8. Children who needed a comparable dental treatment (as regards restorations, pulp treatment, crowns, extraction) on both sides of the same jaw.
排除标准
- •1. Children with learning difficulties or mental disabilities
- •2. Children with active upper respiratory tract infection, any history of a recent cough or cold (less than 2 weeks)
- •3. Children with a known allergy or hypersensitive reaction to either midazolam or fentanyl
- •4. Children at risk of airway obstruction
- •5. Children with any intranasal pathology or congenital anomaly
- •6. Children with a previous history of moderate sedation
研究者
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