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This study has been withdrawn prior to enrollment.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:
Wesley Medical Center
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
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Purpose
The purpose of the study is:
- 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).
- 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.
- 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:
- EEG study patients
- Age less than 18 years
- No contraindication for the use of chloral hydrate or dexmedetomidine
Exclusion Criteria:
- Active, uncontrolled Gastroesophageal Reflux Disease (GERD)
- Active, uncontrolled vomiting
- Current history of apnea requiring apnea monitoring
- Active, current respiratory issues that are different from the baseline status
- Unstable cardiac status
- Craniofacial anomaly with risk of inadequate bag-valve-mask ventilation
- Current use of digoxin, betablockers, or calcium channel blockers
- Current, active cerebral vascular disease
- Patient treated with clonidine within the preceding one month
- Prior history of drug reaction or sedation failure with either drug
Contacts and Locations
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 May 16, 2013