Trial Outcomes & Findings for Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery (NCT NCT00895843)

NCT ID: NCT00895843

Last Updated: 2009-06-01

Results Overview

Number of patients who required rescue medication within 6 hours

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 122 participants
• Primary outcome timeframe: At 6 hours
• Results posted on: 2009-06-01

Participant Flow

Participant milestones

Measure	Conventional Ibuprofen	Brufen Retard
Overall Study STARTED	60	62
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	12	12

Reasons for withdrawal

Measure	Conventional Ibuprofen	Brufen Retard
Overall Study Protocol Violation	12	12

Baseline Characteristics

Protective Analgesia for Postoperative Pain Relief Following Day Case Oral Surgery

Baseline characteristics by cohort

Measure	Conventional Ibuprofen n=60 Participants	Brufen Retard n=62 Participants	Total n=122 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	62 Participants n=7 Participants	122.0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age Continuous	28.71 years STANDARD_DEVIATION 5.809 • n=5 Participants	28.82 years STANDARD_DEVIATION 6.262 • n=7 Participants	28.77 years STANDARD_DEVIATION 6.013 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	16 Participants n=7 Participants	56.0 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	46 Participants n=7 Participants	66.0 Participants n=5 Participants
Region of Enrollment United Kingdom	60 participants n=5 Participants	62 participants n=7 Participants	122.0 participants n=5 Participants

PRIMARY outcome

Timeframe: At 6 hours

Number of patients who required rescue medication within 6 hours

Outcome measures

Measure	Conventional Ibuprofen n=48 Participants	Brufen Retard n=50 Participants
Number of Patients Needing Rescue Medication	32 Participants	29 Participants

SECONDARY outcome

Timeframe: 30 mins, 1 hour, 6 hours, 24 hours and 48 hours after surgery

Mean VAS scores of pain intensity for each time points

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Between 30mins and 48 hours

Time taken for rescue medication requirement

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 48 hours after surgery (end of study)

Patient satisfaction scores

Outcome measures

Outcome data not reported

Adverse Events

Conventional Ibuprofen

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brufen Retard

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

Mr Sin L Yong

University of Manchester

Phone: 01612756806

Email: sin.l.yong@manchester.ac.uk

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place