Dexmedetomidine vs Fentanyl for BMT (DexBMT)

This study has been completed.

Sponsor:

Collaborator:

Hospira, Inc.

Information provided by:

Children's Research Institute

ClinicalTrials.gov Identifier:

NCT00654329

First received: April 3, 2008

Last updated: March 28, 2011

Last verified: March 2011

Results First Received: February 23, 2011

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
Condition:	Otitis
Interventions:	Drug: Saline Drug: Fentanyl Drug: Dexmedetomidine

Participant Flow

Baseline Characteristics

Reporting Groups

	Description
Dexmedetomidine 1microgram/Kilogram	Dexmedetomidine 1microgram/kilogram (mcg/kg) intranasal
Dexmedetomidine 2 Micrograms/Kilogram	Dexmedetomidine 2 micrograms/kilogram (mcg/kg) intranasal
Fentanyl 2 Micrograms/Kilogram	Fentanyl 2 micrograms/kilogram (mcg/kg) intranasal
Normal Saline Placebo	Normal saline placebo intranasal
Total	Total of all reporting groups

Baseline Measures

	Dexmedetomidine 1microgram/Kilogram	Dexmedetomidine 2 Micrograms/Kilogram	Fentanyl 2 Micrograms/Kilogram	Normal Saline Placebo	Total
Number of Participants [units: participants]	23	28	23	27	101
Age [units: participants]
<=18 years	23	28	23	27	101
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0
Age [units: years] Mean ± Standard Deviation	1.92 ± .94	2.17 ± 1.51	2.25 ± 1.47	2.17 ± 1.66	2.14 ± 1.42
Gender [units: participants]
Female	5	10	10	10	35
Male	18	18	13	17	66
Region of Enrollment [units: participants]
United States	23	28	23	27	101

Outcome Measures

1. Primary:

Incidence of Pain [ Time Frame: up to 24 hours ]

Show Outcome Measure 1

2. Secondary:

Length of Stay in PACU [ Time Frame: up to 24 hours ]

Show Outcome Measure 2

Serious Adverse Events

Other Adverse Events

More Information

Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Julia C. Finkel, MD
Organization: Children's National Medical Center
phone: 202-476-4867 ext 4867
e-mail: jfinkel@cnmc.org

No publications provided

Responsible Party:	Julia C. Finkel, MD, Children's National Medical Center
ClinicalTrials.gov Identifier:	NCT00654329 History of Changes
Other Study ID Numbers:	3641, Agreement # 10698
Study First Received:	April 3, 2008
Results First Received:	February 23, 2011
Last Updated:	March 28, 2011
Health Authority:	United States: Institutional Review Board