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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University of Iowa.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University of Iowa
ClinicalTrials.gov Identifier:
NCT01535287
First received: January 20, 2012
Last updated: February 14, 2012
Last verified: February 2012
  Purpose

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).


Condition Intervention Phase
Myringotomy
Drug: Dexmedetomidine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Intramuscular Dexmedetomidine on Emergence Agitation in Children Undergoing With or Without Tube Insertion Under General Anesthesia

Resource links provided by NLM:


Further study details as provided by University of Iowa:

Primary Outcome Measures:
  • Participant's Severity of Emergent Agitation (EA) using the Pediatric Anesthesia Emergence Delirium (PAED) scale in PACU (Post-Op Area). [ Time Frame: 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. ] [ Designated as safety issue: Yes ]

    The aim/measurement of the study is to determine wheather or not a single IM injection of Dexmedetomidine will reduce the severity of EA in children undergoing Bilateral Myringotomy with/without tubes under general anesthesia.

    PAED scale measurements that will be observed/recorded are:

    The child makes eye contact with the caregiver, purposeful actions, aware of surroundings, restless & inconsolable.

    These observations will be assessed 1 time during the child's worse episode of agitation & given a score from 0-4. Scores will be added together to determine degree of ED in child.



Secondary Outcome Measures:
  • 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. [ Time Frame: Participants will be followed immediately following surgery, approximately 30 minutes. Measurements will be observed immediately following subject's awakening from anesthesia. ] [ Designated as safety issue: Yes ]
    Duration of stay in the PACU (Post-Op Area) until discharge criteria are met based on modified PADSS score: level of consciousness, physical activity, hemodynamic stability, respiratory stability, oxygen saturation status, post-operative pain, and post-operative emetic symptoms. Duration of time will be measured in total mintues participate is in PACU until discharged.

  • Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the PADSS score. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Postoperative adverse respiratory events: moderate to severe coughing, oxygen desaturation (SPO2 <90%), breath holding, bronchospasm, aspiration, stridor and/or laryngospasm during PACU duration to discharge. The adverse respiratory events and the adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered. Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.

  • Participant's Severity of Emergent Agitation (EA) in PACU (Post-Op Area) through Day 3 Post-Op using the PADSS score. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Postoperative adverse hemodynamic events: bradycardia-a decrease in heart rate, hypotension-a decrease in systolic blood pressure (both determined as a 30% decrease from baseline) during PACU duration to discharge. The adverse hemodynamic events will be documented by the anesthesia provider in the operating room and by the recovery room nurses in the PACU recovery room. All will be blinded to the drug administered.Measurement will be obtained by "yes"/"no" to each possible adverse respiratory event by anesthesia staff.

  • 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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Postoperative behavioral disturbances are: sleep disturbances, anxiety, eating disturbances. Data regarding postoperative behavioral disturbances will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" to each possible AE by staff based on parent(s) response.

  • 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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Postoperative muscle pain or swelling at the drug injection site. The duration of the stay in the PACU will be retrospectively documented by the research team using EPIC. Data regarding postoperative muscle pain or swelling will be collected by a blinded individual in a telephone interview 3 days after the surgery. Any adverse event will also be documented by the telephone interview. Measurement will be obtained by "yes"/"no" by staff based on parent(s) response.


Estimated Enrollment: 130
Study Start Date: June 2010
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dexmedetomidine
Single injection of Dexmedetomidine (study medication) compared to receiving Placebo in Myringotomy surgery decreases emergence agitation.
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.

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


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.

  Eligibility

Ages Eligible for Study:   1 Year to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01535287

Contacts
Contact: Martin Mueller, M.D. (319) 356-7471 martin-mueller@uiowa.edu
Contact: Pam Jacobs, R.N. anesthesiaclinicalresearchnurses@healthcare.uiowa.edu

Locations
United States, Iowa
University of Iowa Hospital and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Martin Mueller, M.D.    319-356-7471    martin-mueller@uiowa.edu   
Contact: Pam Jacobs, R.N.       anesthesiaclinicalresearchnurses@healthcare.uiowa.edu   
Principal Investigator: Martin Mueller, M.D.         
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Martin Mueller, M.D. University of Iowa Hospital and Clinics
  More Information

No publications provided

Responsible Party: University of Iowa
ClinicalTrials.gov Identifier: NCT01535287     History of Changes
Other Study ID Numbers: 201006723
Study First Received: January 20, 2012
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Iowa:
Dexmedetomidine
Emergence Agitation
Myringotomy
Children
General Anesthesia

Additional relevant MeSH terms:
Anesthetics
Dexmedetomidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Analgesics, Non-Narcotic
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014