Trial Outcomes & Findings for Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis (NCT NCT01195116)

Results Overview

It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average

Results posted on

2015-04-15

Participant milestones
Measure	Dexmedetomidine Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs. Dexmedetomidine: 1 mcg/kg/hour	Normal Saline Normal Saline: 1mcg/kg/hr
Overall Study STARTED	21	20
Overall Study COMPLETED	21	20
Overall Study NOT COMPLETED	0	0

Withdrawal data not reported

Usefulness of Dexmedetomidine on Post-operative Pain Management in Patients With Interstitial Cystitis

Baseline characteristics by cohort
Measure	Dexmedetomidine n=21 Participants Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs. Dexmedetomidine: 1 mcg/kg/hour	Normal Saline n=20 Participants Normal Saline: 1mcg/kg/hr	Total n=41 Participants Total of all reporting groups
Age, Continuous	48.32 years STANDARD_DEVIATION 10.98 • n=5 Participants	45.25 years STANDARD_DEVIATION 15.25 • n=7 Participants	47 years STANDARD_DEVIATION 13.24 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	20 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants	20 participants n=7 Participants	41 participants n=5 Participants

Timeframe: Assessed every 15 minutes while in Post Anesthesia Care Unit until discharged home, which was approximately 10 times on the average

It is a measurement instrument for subjective characteristics or attitudes towards pain that cannot be directly measured.

Outcome measures
Measure	Dexmedetomidine n=21 Participants Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs. Dexmedetomidine: 1 mcg/kg/hour	Normal Saline n=20 Participants Normal Saline: 1mcg/kg/hr
Change in Pain Score (1-10, 10 is Most Pain) From Baseline, to Average Post op Pain Score in PACU	-1.46 units on a scale Standard Deviation 3.33	-.025 units on a scale Standard Deviation 4.88

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Rochester

Phone: 5852751384