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

NCT ID: NCT01535287

Last Updated: 2018-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-04
• Study Completion Date: 2013-10-08

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).

Detailed Description

Emergence agitation (EA) is common in children, especially in the preschool age group who undergo general anesthesia. It has been described as a mental disturbance during the recovery from general anesthesia and can consist of hallucinations, delusions and confusion in the child. To the parent or caregivers this may be seen as moaning, restlessness, involuntary physical activity & thrashing about in bed. Emergence agitation (EA) can result in the child losing their intravenous therapy (IV) access & bodily injury. Some agitated children may retain vivid memories about their negative experience waking up from anesthesia. This can result in seeing new behaviors by the child such as anxiety, nighttime crying and temper tantrums. Dexmedetomidine given as an injection into the muscle of children is considered investigational, which means it hasn't been approved by the U.S. FDA for treatment of this problem in children.

Immediately following surgery measurements of eye contact, purposeful actions, aware of surroundings, restless and crying are observed and recorded using the Pediatric Anesthesia Emergence Delirium (PAED) scale in PACU.

Follow-up is made approximately 3 days after surgery by phone call or/and email with parent(s) to see if child has experienced any of the following: sleep disturbances, anxiety, eating disturbances, postoperative muscle pain or swelling at the injection site.

Conditions

Myringotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dexmedetomidine

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: 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.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Dexmedetomidine

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Precedex

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Martin Mueller

OTHER

Sponsor Role: lead

Responsible Party

Martin Mueller

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Martin Mueller, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Iowa Hospital and Clinics

Locations

University of Iowa Hospital and Clinics

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

201006723

Identifier Type: -

Identifier Source: org_study_id