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临床试验/CTRI/2014/01/004335
CTRI/2014/01/004335已完成4 期

A comparison of oral midazolam with intranasal dexmedetomidine in paediatric patients requiring restorative dental treatment

Post Graduate Institute of Medical Education and Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010年1月11日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Dose of ketamine required to keep acceptable Houpts scores for procedure

研究概览

简要总结

Sedation is frequently desired in young childrenundergoing day-care dental treatments.Conscious sedation is a safe techniquewhich offers sedation, relief of pain and anxiety with minimal systemic risks.Midazolam is the conventionally used sedative in a wide variety of applications.exmedetomidine is a newer alpha-2 agonist which provides sedation, analgesiaand anxiolysis and has been used intravenously for pediatric proceduralsedation in a variety of settings such as radiological imaging (MRI, CT Scan),awake craniotomies and cardiac catheterization.We planned this study to comparethe efficacy of intranasal Dexmedetomidine with oral Midazolam for sedation inuncooperative children undergoing restorative dental procedures between 2-6years of age. After institutional ethics committee approval, and writteninformed consent from parents, uncooperative children aged 2-6years wereselected from the outpatient department of Oral Health Centre of our Institute.Only those children who were scheduled for restorative procedures (RCT, tooth extractions,fillings etc.) of less than 45mins of duration were enrolled for the study.Children were randomly assigned to two groups for premedication usingcomputer-generated random number chart 20 mins after EMLA cream application. Group D received intranasal Dexmedetomidine 2.5mcg/kg, (half thetotal dose loaded in a 2cc syringe undiluted in each nostril) and 5ml oralhoney, as control. Group M receivedoral Midazolam 0.5mg/kg mixed with 5 ml honey and sterile water nasal drops (ina 2cc syringe equal volume in both nostrils) as control. IV cannulation wasattempted 30 minutes after premedication at the site pre-treated with EMLAcream. The children were then shifted to the dental chair and the child’sbehavior during dental procedure was assessed using Houpt’s behavior ratingscale of movement. A score of 3 was accepted as favourable. To score theoverall behavior and outcome of treatment The Houpt’s overall behavior ratingscale was used (Appendix 3).The optimum score which was to be achieved was >3.A score of 5/6 was  considered as the best score. IV Ketamineboluses 0.5mg/kg were given till optimal sedation for the procedure is achieved*.* The duration of procedure and thetotal dose of the Ketamine administered was recorded.Intra-procedural vitals likeHR, ECG, NIBP and Oxygen Saturation were monitored continuously at regular 10minute intervals.The children were kept in observation area for a period of60minutes after the end of the procedure. At the end of procedure, thedentist’s opinion was obtained for the overall experience in performing theprocedure as either Good/Fair/Bad. The children were then discharged accordingto the modified Aldrette scoring criteria (Appendix 4). A score of 9/10 wasconsidered as the sufficient criteria for discharge. The parents were contactedby making a telephone call in the evening to elicit any untoward effects orabnormality in the behaviour of their child. A note was made of the same, ifany of these was present.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

入排标准

年龄范围
2.00 Year(s) 至 6.00 Year(s)(—)
性别
All

入选标准

  • uncooperative children aged 2-6years who were scheduled for restorative procedures (RCT, tooth extractions, fillings etc.) of less than 45mins of duration.

排除标准

  • Patients with previous exposure to dental sedation, neurodevelopmental anomalies, abnormal cardiac anatomy, Craniofacial anatomical defects , allergy to EMLA cream, allergy to study drugs.

结局指标

主要结局

Dose of ketamine required to keep acceptable Houpts scores for procedure

时间窗: during the 20-30 minutes of proceudre

次要结局

  • Ramsay sedation Scores, Heart rate, non invasive blood pressure(Ramsay sedation score-before premedication, and 15 and 30 minutes after premedication, after procedure)

研究者

发起方
Post Graduate Institute of Medical Education and Research
申办方类型
Research institution and hospital

研究点 (1)

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