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Effect of Dexmedetomidine Versus Midazolam Versus a Combination of the Two as a Premedication for Children Undergoing Bilateral Myringotomy Tube Insertion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Nemours Children's Clinic

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Premedication with Midazolam Drug: Combination of Dexmedetomidine with Midazolam

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 6 mo-4 years
  • ASA classification 1 or 2
  • Vital signs, namely heart rate and blood pressure within the normal range for each patient's age group

Exclusion Criteria:

  • Known allergies to midazolam or dexmedetomidine
  • Baseline vitals outside the range listed above
  • Personal or family history of malignant hyperthermia
  • Genetic abnormalities predisposing to altered hemodynamics or difficult airway
  • ASA physical status 3 or greater
  • Known cardiac abnormalities

Information from the National Library of Medicine

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 identifier (NCT number): NCT02134327

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Contact: Jessie J Budzinski, M.D. 646-678-0825

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United States, Delaware
A.I. Dupont Hospital for Children
Wilmington, Delaware, United States, 19803
Contact: Jessie Budzinski, MD    646-678-0825   
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         
Sponsors and Collaborators
Nemours Children's Clinic
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Responsible Party: Nemours Children's Clinic Identifier: NCT02134327    
Other Study ID Numbers: JB004-1
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents