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Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

S

Shaare Zedek Medical Center

Status

Unknown

Conditions

Insomnia

Treatments

Drug: midazolam
Other: clown doctor

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

2 to 12 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

80 participants in 2 patient groups

midazolam
Active Comparator group
Treatment:
Drug: midazolam
clown doctor
Active Comparator group
Treatment:
Other: clown doctor

Trial contacts and locations

1

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Central trial contact

Yaacov Gozal, MD

Data sourced from clinicaltrials.gov

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