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

NCT01535287 | Completed Phase 4 Results DMC

• 1 other identifier: 201006723
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dexmedetomidine; Emergence Agitation; Myringotomy; Children; General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Participant's Severity of Emergent Agitation (EA) Using the Pediatric Anesthesia Emergence Delirium (PAED) Scale in PACU (Post-Op Area).

  The aim/measurement of the study is to determine whether or not a single IM injection of Dexmedetomidine will reduce the severity of Emergent Agitation (EA) in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia. We used the only validated scale to assess the severity of post operative emergence delirium in pediatrics. This Pediatric Anesthesia Emergence Delirium (PAED) scale is a composite score of the following items: 1. Makes eye contact with caregiver. 2. Child's actions are purposeful. 3. Child aware of his/her surroundings. 4. The child is restless. 5. The child is inconsolable. Items 1, 2, and 3 are reversed scored as follows: 4-not at all, 3-a little, 2-quite a bit, 1-very much, 0-extremely. Items 4 and 5 are scored as follows: 0-not at all, 1-a little, 2-quite a bit, 3-very much, 4-extremely. The total score will range from 0 to 20; with 0 indicating no emergence delirium and 20 indicating extreme emergence delirium.

  Participants will be followed for the duration of first PACU recovery step, an expected average visit of 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

Secondary Outcomes (5)

• Duration of Stay in PACU

  Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia.

• Respiratory Complications Peri-Operative

  Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

• Hemodynamic Instability

  Participants will be followed for the duration immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

• Post-Operative Behavioral Disturbances

  Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

• Muscle Pain

  Participants will be followed for the duration immediately following surgery, approximately 30 minutes, through approximately Day 3 post-surgery. Measurements will be observed immediately following subject's awakening from anesthesia by Anesthesia staff.

Study Arms (2)

Dexmedetomidine

ACTIVE COMPARATOR

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

Drug: Dexmedetomidine

Placebo

PLACEBO COMPARATOR

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

Drug: Dexmedetomidine

Interventions

Dexmedetomidine DRUG

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.

Also known as: Precedex

Dexmedetomidine; Placebo

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Martin Mueller: lead

Study Sites (1)

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Emergence Delirium

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

There were no limitations or caveats that prevented us from completion of the study.

Results Point of Contact

• Title: Martin Mueller
• Organization: University of Iowa

martin-mueller@uiowa.edu

3193562633

Study Officials

• Martin Mueller, M.D.

  University of Iowa Hospital and Clinics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 20, 2012
• First Posted: February 17, 2012
• Study Start: January 4, 2011
• Primary Completion: October 8, 2013
• Study Completion: October 8, 2013
• Last Updated: July 9, 2018
• Results First Posted: July 9, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)