Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

NCT00464451 | Withdrawn Phase 2 DMC

• 1 other identifier: Dex for Ped EEG
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is:

1. 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. 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. 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.

Conditions

Procedural Sedation

Outcome Measures

Primary Outcomes (5)

• Sedation success with EEG study completion

  2 hours

• Degree of sedation medication induces patient agitation.

  4 hours

• Variance of vital signs from baseline during medication induced sedation for EEG study

  4 hours

• Time to recovery from sedation.

  4 hours

• Occurrence of adverse events.

  24 hours

Secondary Outcomes (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.

  2 hours

Study Arms (2)

1

EXPERIMENTAL

Dexmedetomidine sedated pediatric patients undergoing EEG study.

Drug: Dexmedetomidine

2

ACTIVE COMPARATOR

Chloral hydrate sedated pediatric patients undergoing sedated EEG study.

Drug: Chloral hydrate

Interventions

Dexmedetomidine DRUG

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.

1

Chloral hydrate DRUG

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.

2

Eligibility Criteria

• Age: 4 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• EEG study patients
• Age less than 18 years
• No contraindication for the use of chloral hydrate or dexmedetomidine

You may not qualify if:

• 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

Sponsors & Collaborators

• Wesley Medical Center: lead
• Hospira, now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

Pediatric Sedation Unit, Wesley Medical Center

Wichita, Kansas, 67214, United States

Location

MeSH Terms

Interventions

Dexmedetomidine; Chloral Hydrate

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethylene Glycols; Glycols; Alcohols; Organic Chemicals

Study Officials

• Lindall E Smith, MD

  University of Kansas School of Medicine-Wichita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 19, 2007
• First Posted: April 23, 2007
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: May 1, 2011
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

US (1)