Dexmedetomidine Versus Chloral Hydrate for Pediatric Sedation During EEG

• Status: Withdrawn
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wesley Medical Center
• Collaborators: Hospira, Inc.; Hospira, now a wholly owned subsidiary of Pfizer
• Treatments: Chloral Hydrate; Dexmedetomidine

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