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Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

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: NCT00886314
Recruitment Status : Unknown
Verified February 2009 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 22, 2009
Last Update Posted : October 20, 2009
Information provided by:
Shaare Zedek Medical Center

Brief Summary:
The purpose of the present investigation will be to determine whether a combination of clown doctor and parental presence is more effective than a combination of sedative premedication and parental presence for reducing anxiety in children and their parents and for improving parental satisfaction.

Condition or disease Intervention/treatment Phase
Insomnia Drug: midazolam Other: clown doctor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Study Start Date : June 2009
Estimated Primary Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Active Comparator: midazolam Drug: midazolam
Children in this group will be premedicated with oral midazolam syrup (0.3 at least 15 minutes before the surgical procedure and one of the parents will be present throughout the anesthesia induction process.

Active Comparator: clown doctor Other: clown doctor
Children will interact with clowns before entering the operating room and will stay with them and one of the parents throughout the anesthesia induction process.

Primary Outcome Measures :
  1. Preoperative anxiety [ Time Frame: Prior to induction of anesthesia ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • children aged 2 to 12 yr, scheduled for minor surgery under general anesthesia will be included in the present study.

Exclusion Criteria:

  • Children with prematurity, development delay, previous anesthetic experience will be excluded from this study

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): NCT00886314

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Contact: Yaacov Gozal, MD 972-2-6555 614

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Shaare Zedek Medical Center Recruiting
Jerusalem, Israel, 91031
Sponsors and Collaborators
Shaare Zedek Medical Center
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Principal Investigator: Yaacov Gozal, MD Shaare Zedek Medical Center, Jerusalem, Israel

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Responsible Party: Yaacov Gozal, MD, Shaare Zedek Medical Center Identifier: NCT00886314     History of Changes
Other Study ID Numbers: 12345
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: October 20, 2009
Last Verified: February 2009
Keywords provided by Shaare Zedek Medical Center:
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action