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Myringotomy | The Effect of Intramuscular Dexmedetomidine on Emergence Agitation in Children Undergoing With or Without Tube Insertion Under General Anesthesia

Myringotomy research study

What is the primary objective of this study?

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).

Who is eligible to participate?

Inclusion Criteria: - ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.) - Between the ages of 1 and 10 years - Undergoing BMT under general anesthesia. Exclusion Criteria: - ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes) - Congenital diseases - Coagulation disorders - Known allergic reaction to dexmedetomidine - Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions - Severe upper airway infection - Predicted difficult airway - Preexisting psychiatric disorders

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Myringotomy

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:DexmedetomidineActive 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.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

DexmedetomidineSingle injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.

PlaceboSingle injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.

Study Status

Unknown status

Start Date: June 2010

Completed Date: January 2013

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Participant's Severity of Emergent Agitation (EA) using the Pediatric Anesthesia Emergence Delirium (PAED) scale in PACU (Post-Op Area).

Secondary Outcome: Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the Postanesthesia Discharge Scoring System (PADSS) score.

Study sponsors, principal investigator, and references

Principal Investigator: Martin Mueller, M.D.

Lead Sponsor: University of Iowa

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01535287

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