Use of Dexmedetomidine to Reduce Emergence Delirium Incident in Children

NCT00857727 | Completed Phase 3 Results DMC

• 1 other identifier: Dex Peds 08-088
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Emergence delirium (ED) from general anesthesia posts risk and harm to pediatric population undergo general anesthesia. The purpose of the study is to compare the use of dexmedetomidine versus placebo in reducing the incidence and severity of ED in a pediatric neurosurgical population.

Conditions

Agitation; Anesthesia; Pediatrics

Keywords

Dexmedetomidine; Emergence Delirium; Agitation; Pediatric; Anesthesia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Emergence Delirium

  Emergence Delirium (ED) during the 15-45min. post-op period as assessed by the Cole Score. (Cole Score 3-5 = ED). The Cole Scale is an ordinal ranking of ED (1=sleeping; 2=awake, calm; 3=irritable, crying; 4=inconsolable, crying; 5=severe restlessness, disorientation).

  15-45 minutes post-op

Secondary Outcomes (8)

• Vital Signs (Heart Rate, Blood Pressure, Respiratory Rate and Pulse Oximetry) Will be Continuously Monitored in the PICU

  24 hours

• Weight

  Baseline

• Length of Anesthesia

  Day 1

• Length of Surgery

  Day 1

• Total Study Drug

  Day 1

Study Arms (2)

Drug

EXPERIMENTAL

Dexmedetomidine

Drug: Dexmedetomidine

Control

PLACEBO COMPARATOR

Normal Saline IV solution

Drug: Saline

Interventions

Dexmedetomidine DRUG

Dexmedetomidine will be dissolved in saline. An initial loading dose of 1.0 mg/kg given over 10 minutes followed by a continuous infusion at 0.4-0.7 mg/kg/hour. Beginning approximately one hour prior to end of surgery and continuing for one hour of recovery in the PACU and the PICU. This, the maximum dose for any one patient will be 2.4 mg/kg

Also known as: Precedex

Drug

Saline DRUG

Given by a continuous infusion

Also known as: Phosphate buffered saline, PBS

Control

Eligibility Criteria

• Age: 6 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children age 6 months through 17 years of age undergoing interventional neuroradiologic procedures at our hospital under general anesthesia
• Patients classify as an ASA (American Society of Anesthesiologists) I-III
• Have not received anesthetic for over 30 days from previous procedures

You may not qualify if:

• Receiving digoxin therapy from the study
• Severe congestive heart failure or pulmonary hypertension requiring vasodilators
• Disease processes other than that associated with their intracranial pathology, such as hepatic or renal dysfunction

Sponsors & Collaborators

• St. Luke's-Roosevelt Hospital Center: lead

Study Sites (1)

St Luke's-Roosevelt Hospital Center

New York, New York, 10019, United States

Location

Related Publications (5)

• Blaine Easley R, Brady KM, Tobias JD. Dexmedetomidine for the treatment of postanesthesia shivering in children. Paediatr Anaesth. 2007 Apr;17(4):341-6. doi: 10.1111/j.1460-9592.2006.02100.x.

  PMID: 17359402 BACKGROUND

• Isik B, Arslan M, Tunga AD, Kurtipek O. Dexmedetomidine decreases emergence agitation in pediatric patients after sevoflurane anesthesia without surgery. Paediatr Anaesth. 2006 Jul;16(7):748-53. doi: 10.1111/j.1460-9592.2006.01845.x.

  PMID: 16879517 BACKGROUND

• Guler G, Akin A, Tosun Z, Ors S, Esmaoglu A, Boyaci A. Single-dose dexmedetomidine reduces agitation and provides smooth extubation after pediatric adenotonsillectomy. Paediatr Anaesth. 2005 Sep;15(9):762-6. doi: 10.1111/j.1460-9592.2004.01541.x.

  PMID: 16101707 BACKGROUND

• Ibacache ME, Munoz HR, Brandes V, Morales AL. Single-dose dexmedetomidine reduces agitation after sevoflurane anesthesia in children. Anesth Analg. 2004 Jan;98(1):60-63. doi: 10.1213/01.ANE.0000094947.20838.8E.

  PMID: 14693585 BACKGROUND

• Walker J, Maccallum M, Fischer C, Kopcha R, Saylors R, McCall J. Sedation using dexmedetomidine in pediatric burn patients. J Burn Care Res. 2006 Mar-Apr;27(2):206-10. doi: 10.1097/01.BCR.0000200910.76019.CF.

  PMID: 16566567 BACKGROUND

MeSH Terms

Conditions

Psychomotor Agitation; Emergence Delirium

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Delirium; Confusion; Postoperative Complications; Pathologic Processes; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

Methodology used cannot determine whether undescribed prolonged effect of DEX is related to the DEX or to increased activity levels in the placebo group.

Results Point of Contact

• Title: Dr. Jinu Kim
• Organization: Mount Sinai St. Luke's

JiKim@chpnet.org

212-523-6121

Study Officials

• Jolie Narang, M.D.

  St. Luke's-Roosevelt Hospital Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2009
• First Posted: March 9, 2009
• Study Start: August 1, 2009
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: November 27, 2018
• Results First Posted: November 27, 2018

Record last verified: 2018-11

Locations

US (1)