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Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

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ClinicalTrials.gov Identifier: NCT00464451
Recruitment Status : Withdrawn (Unable to obtain approval from FDA for use of chloral hydrate)
First Posted : April 23, 2007
Last Update Posted : November 3, 2016
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Procedural Sedation Drug: Dexmedetomidine Drug: Chloral hydrate Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Double Blinded,Randomized Controlled Trial of Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG
Study Start Date : August 2009
Primary Completion Date : December 2010
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Sedation success with EEG study completion [ Time Frame: 2 hours ]
  2. Degree of sedation medication induces patient agitation. [ Time Frame: 4 hours ]
  3. Variance of vital signs from baseline during medication induced sedation for EEG study [ Time Frame: 4 hours ]
  4. Time to recovery from sedation. [ Time Frame: 4 hours ]
  5. Occurrence of adverse events. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00464451


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

Responsible Party: Lindall E.Smith, Medical Doctor, Wesley Medical Center
ClinicalTrials.gov Identifier: NCT00464451     History of Changes
Other Study ID Numbers: Dex for Ped EEG
First Posted: April 23, 2007    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Dexmedetomidine
Chloral Hydrate
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
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