Effect of Dexmedetomidine Versus Midazolam Versus a Combination of the Two as a Premedication for Children Undergoing Bilateral Myringotomy Tube Insertion
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|ClinicalTrials.gov Identifier: NCT02134327|
Recruitment Status : Unknown
Verified April 2014 by Nemours Children's Clinic.
Recruitment status was: Not yet recruiting
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Following an obtained written consent, a child presenting for ear tube surgery will be randomized into one of three groups for receiving a premedication. One group will be the current therapy with midazolam, another group will be another drug dexmedetomidine, and the third group will be a combination of midazolam plus dexmedetomidine. Observers in the study (the investigators fellow and advance practice nurse) will not know which group each patient belongs, and will then make three separate assessments: preoperative sedation, mask acceptance, and postoperative delirium.
Mask acceptance: Induction of anesthesia, or the beginning of the process for the patient to fall asleep and lose consciousness, involves placing a mask over there face, specifically the nose and mouth. The mask is connected to their anesthesia machine via tubing, or a circuit, through which their anesthetic gases flow. Some children fight the mask as it can be seen as new and frightening. Other children, sometimes depending on how sedated they are after receiving a premedication, do not fear the mask on their face and do not resist induction. How well or easily this happens can be described as "mask acceptance." Postoperative delirium can be seen in patients of any age or after any surgery and can be better defined as a mental disturbance during the recovery from general anesthesia consisting of hallucinations, delusions, and confusion manifested by moaning, restlessness, involuntary physical activity, and thrashing about in bed. It has been considered a common postanesthetic problem in children and adults since 1960.
Each patient will then have a set of numbers for each scale; following conclusion of the study the investigators will be able see which drug each patient received and statistical analysis can be completed. The investigators goal is to see if there is any difference in any of the scales depending which medication was administered. The scales to be utilized include the pre-operative sedation scale, the mask acceptance scale, and the pediatric emergence delirium scale.
|Condition or disease||Intervention/treatment||Phase|
|Pre Operative Sedation Mask Acceptance Post Operative Delerium||Drug: Combination of Dexmedetomidine with Midazolam||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Dexmedetomidine Versus Midazolam Versus a Combination of the Two as a Premedication for Children Undergoing Bilateral Myringotomy Tube Insertion: A Randomized, Blinded Study|
|Study Start Date :||August 2014|
|Estimated Primary Completion Date :||April 2015|
|Experimental: Premedication with Midazolam||
Drug: Combination of Dexmedetomidine with Midazolam
- Post operative anesthesia emergence delerium scale [ Time Frame: From beginning of when patient receives medication for assessing preoperative sedation to recovery room when postoperative delerium is assessed. This whole process takes approximately 90 minutes. ]The primary outcome will be which group of subjects have different PAED or emergence derlium scale scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134327
|Contact: Jessie J Budzinski, M.D.||646-678-0825||Jessie.Budzinski@nemours.org|
|United States, Delaware|
|A.I. Dupont Hospital for Children|
|Wilmington, Delaware, United States, 19803|
|Contact: Jessie Budzinski, MD 646-678-0825 Jessie.Budzinski@nemours.org|
|Principal Investigator: Jessie J Budzinski, MD|
|Sub-Investigator: Dinesh Choudhry, MD|
|Sub-Investigator: Randall Brenn, MD|
|Sub-Investigator: Karen Sacks, APN|
|Sub-Investigator: Michelle Petrie, MD|
|Sub-Investigator: Larry Heredia, CRNA|