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Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia

NCT01535287 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-07-09

Study results available
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Summary

The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia.

The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).

Conditions

  • Myringotomy

Interventions

DRUG

Dexmedetomidine

Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline). All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider.

Sponsors & Collaborators

  • Martin Mueller

    lead OTHER

Principal Investigators

  • Martin Mueller, M.D. · University of Iowa Hospital and Clinics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-04
Primary Completion
2013-10-08
Completion
2013-10-08

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01535287 on ClinicalTrials.gov