Comparison of nebulised dexmedetomedine,ketamine and fentanyl for premedication in children undergoing infraumbilical surgery
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Degree of sedation when the child first seen in the OR 30 min after sedation based on Ramsay sedation scale.
研究概览
简要总结
The study is a randomized, double-blinded study .
This study is designed to evaluate and compare the efficacy and safety of nebulized dexmedetomidine, nebulized ketamine, and nebulized fentanyl as a premedication prior to general anaesthesia (GA) in paediatric patients. All patients who are allergic to the drugs used in this study ,Congenital heart disease,developmental delay and parental refusal are excluded from the study.Study will be done in 3-8 years of age group.
Patients will be randomly categorized into 3 equal groups (30 each) using a random numbers table with group allocation concealed in sealed opaque envelopes. Group K patients will be premedicated with nebulized ketamine solution (2 mg/kg), group D patients will be premedicated with nebulized dexmedetomidine solution (2 μg/kg), and group F will be premedicated with nebulized fentanyl(2mcg/kg).The observers and attending anaesthesiologists will be blinded to the drug being administered. A researcher who will not participate in the evaluation will administer the drugs to all the children in nebuliser.
OUTCOMES:
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The primary end point is the degree of sedation when the child was first seen in the OR 30 minutes after sedation, based on the Ramsay Sedation Scale..
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The secondary end points are parental separation, perioperative HR and BP, hemodynamic changes, sedation at emergence,post operative Face ,Legs ,Activity, Cry ,Consolability (FLACC) pain scale, the incidence of Emergence Agitation (EA),adverse effects.
REFERENCES
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Kain ZN, Caldwell-Andrews AA, Krivutza DM, Weinberg ME, Wang SM, Gaal D. Trends in the practice of parental presence during induction of anesthesia and the use of preoperative sedative premedication in the United States, 1995-2002: results of a follow-up national survey. Anesth Analg. 2004;98:1252–9
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Hosey MT, Macpherson LM, Adair P, Tochel C, Burnside G, Pine C. Dental anxiety, distress at induction and postoperative morbidity in children undergoing tooth extraction using general anaesthesia. Br Dent J. 2006;200:39–43
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Hosey MT, Asbury AJ, Bowman AW, Millar K, Martin K, Musiello T, Welbury R. The effect of transmucosal 0.2 mg/kg midazolam premedication on dental anxiety, anaesthetic induction and psychological morbidity in children undergoing general anaesthesia for tooth extraction. Br Dent J. 2009;207:E2
4.Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004;99:1648–54 6. Warrington SE, Kuhn RJ. Use of intranasal medications in pediatric patients. Orthopedics. 2011;34:456–9
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 3.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •parents consent 2.age group 3-8 yrs 3.type of surgery included:infraumbilical surgery 4.ASA physical status 1 and 2.
排除标准
- •1.Parents refusal 2.All patients who have history of allergies to any of the drugs used in the study.
- •3.Congenital disease 4 Developmental delay.
结局指标
主要结局
Degree of sedation when the child first seen in the OR 30 min after sedation based on Ramsay sedation scale.
时间窗: 30 min
次要结局
- Parental seperation ,perioperative HR and BP,hemodynamical changes,sedation at emergence,post operative Face,Legs,Activity,Cry,Consolobility(FLACC) pain scale,the incidence of emergence agitation (EA),adverse events.(perioperative assessment:0,5,10,20,30 min)