Trial Outcomes & Findings for Analgetic and Anxiolytic Effect of Preoperative Pregabalin (NCT NCT00353704)

Results Overview

The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

50 participants

Primary outcome timeframe

120 minutes after surgery

Results posted on

2011-07-20

Participant Flow

recruitment period november 2005 until june 2008

Participant milestones

Participant milestones
Measure	Pregabalin	Placebo
Overall Study STARTED	25	25
Overall Study COMPLETED	22	24
Overall Study NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Pregabalin	Placebo
Overall Study Protocol Violation	3	1

Baseline Characteristics

Analgetic and Anxiolytic Effect of Preoperative Pregabalin

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pregabalin n=25 Participants	Placebo n=25 Participants	Total n=50 Participants Total of all reporting groups
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age Continuous	44 years STANDARD_DEVIATION 11 • n=5 Participants	43 years STANDARD_DEVIATION 8 • n=7 Participants	43 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	12 Participants n=7 Participants	24 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Region of Enrollment Norway	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: 120 minutes after surgery

The visual analogue scale (VAS) was used for registration of the pain intensity at rest. The score ranges from 0-100, where 0 means no pain and 100 means maximal pain. Higher values represent a worse outcome.

Outcome measures

Outcome measures
Measure	Pregabalin n=22 Participants	Placebo n=24 Participants
Mean VAS Pain (Visual Analogue Scale)at Rest (0-100 mm)	11.7 Units on a scale Standard Deviation 9.6	22.5 Units on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: 240 minutes

Patients were equipped with a morphine PCA (patient controlled analgesia) for 24 hours after surgery. So they could administrate morphine intravenously by pressing a button. The sum of morphine was registered as " cumulated opioid consumption (milligram)

Outcome measures

Outcome measures
Measure	Pregabalin n=22 Participants	Placebo n=24 Participants
Morphine (Opioid) Consumption Cumulated	7.3 mg Standard Deviation 6.3	16.0 mg Standard Deviation 13.2

Adverse Events

Pregabalin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ulrich J Spreng

Baerum Hospital

Phone: 004798499184

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place