Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

This study has been withdrawn prior to enrollment.
(Unable to obtain approval from FDA for use of chloral hydrate)
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by:
Wesley Medical Center
ClinicalTrials.gov Identifier:
NCT00464451
First received: April 19, 2007
Last updated: January 13, 2010
Last verified: January 2010
  Purpose

The purpose of the study is:

  1. To compare the efficacy of dexmedetomidine versus chloral hydrate as pediatric sedation agents for EEG studies. Efficacy will be determined by successful EEG study completion and by minimum degree of sedation induced patient agitation (SAS score).
  2. To compare the safety and adverse event profile of dexmedetomidine versus chloral hydrate during sedation of pediatric patients for EEG studies. Comparison will be based on variance of vital signs (HR, MAP, RR, O2SAT, ETCO2) from baseline during sedation as well as the frequency of adverse events during and following sedation.
  3. To compare quality of EEG recording obtained with dexmedetomidine or chloral hydrate and to those of non-sedated pediatric EEG studies. Quality will be determined by the degree of background beta-wave activity.

Condition Intervention Phase
Procedural Sedation
Drug: Dexmedetomidine
Drug: Chloral hydrate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Double Blinded,Randomized Controlled Trial of Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

Resource links provided by NLM:


Further study details as provided by Wesley Medical Center:

Primary Outcome Measures:
  • Sedation success with EEG study completion [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
  • Degree of sedation medication induces patient agitation. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
  • Variance of vital signs from baseline during medication induced sedation for EEG study [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
  • Time to recovery from sedation. [ Time Frame: 4 hours ] [ Designated as safety issue: Yes ]
  • Occurrence of adverse events. [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • EEG record quality (degree of background beta-wave activity, levels of consciousness achieved, and degree of movement artifact) between sedated and non-sedated groups. [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: August 2009
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Dexmedetomidine sedated pediatric patients undergoing EEG study.
Drug: Dexmedetomidine
Dexmedetomidine 3 micrograms per kilogram per os; subsequent dose of 1 microgram per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.
Active Comparator: 2
Chloral hydrate sedated pediatric patients undergoing sedated EEG study.
Drug: Chloral hydrate
Chloral hydrate 75 milligrams per kilogram per os; subsequent dose of 25 milligrams per kilogram per os if necessary to treat inadequate sedation 30 minutes following initial dosing.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. EEG study patients
  2. Age less than 18 years
  3. No contraindication for the use of chloral hydrate or dexmedetomidine

Exclusion Criteria:

  1. Active, uncontrolled Gastroesophageal Reflux Disease (GERD)
  2. Active, uncontrolled vomiting
  3. Current history of apnea requiring apnea monitoring
  4. Active, current respiratory issues that are different from the baseline status
  5. Unstable cardiac status
  6. Craniofacial anomaly with risk of inadequate bag-valve-mask ventilation
  7. Current use of digoxin, betablockers, or calcium channel blockers
  8. Current, active cerebral vascular disease
  9. Patient treated with clonidine within the preceding one month
  10. Prior history of drug reaction or sedation failure with either drug
  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: NCT00464451

Locations
United States, Kansas
Pediatric Sedation Unit, Wesley Medical Center
Wichita, Kansas, United States, 67214
Sponsors and Collaborators
Wesley Medical Center
Hospira, Inc.
Investigators
Principal Investigator: Lindall E Smith, MD University of Kansas School of Medicine-Wichita
  More Information

No publications provided

Responsible Party: Lindall E. Smith MD, Wesley Medical Center
ClinicalTrials.gov Identifier: NCT00464451     History of Changes
Other Study ID Numbers: Dex for Ped EEG
Study First Received: April 19, 2007
Last Updated: January 13, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014