Trial Outcomes & Findings for Effects of Perioperative Intravenous Dexamethasone on Pain in Out Patient Knee Surgery (NCT NCT01149616)

Results Overview

Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

82 participants

Primary outcome timeframe

24 hours

Results posted on

2017-07-07

Participant Flow

2010

Participant milestones

Participant milestones
Measure	Intervention Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	Placebo placebo placebo: placebo administered IV x1
Overall Study STARTED	41	41
Overall Study COMPLETED	41	41
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=41 Participants Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	Placebo n=41 Participants placebo placebo: placebo administered IV x1	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=41 Participants	0 Participants n=82 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=41 Participants	41 Participants n=41 Participants	82 Participants n=82 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants	0 Participants n=41 Participants	0 Participants n=82 Participants
Sex: Female, Male Female	15 Participants n=41 Participants	16 Participants n=41 Participants	31 Participants n=82 Participants
Sex: Female, Male Male	26 Participants n=41 Participants	25 Participants n=41 Participants	51 Participants n=82 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	41 participants n=41 Participants	41 participants n=41 Participants	82 participants n=82 Participants

PRIMARY outcome

Timeframe: 24 hours

Patients were instructed to select a number between zero and ten to indicate the degree of pain they experience (zero being no pain and ten being the worst pain they could imagine). Therefore, ten is worse than zero.

Outcome measures

Outcome measures
Measure	Intervention n=41 Participants Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	Placebo n=41 Participants placebo placebo: placebo administered IV x1
Post Operative VAS Pain Scale	1.88 units on a scale Standard Deviation 0.3	3.73 units on a scale Standard Deviation 0.5

SECONDARY outcome

Timeframe: 24 hours

Patients were requested to record the number of prescribed oral analgesic (oxycodone 5 mg/aceteminophen 325 mg) tablets taken for the first 24 hours following discharge

Outcome measures

Outcome measures
Measure	Intervention n=41 Participants Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	Placebo n=41 Participants placebo placebo: placebo administered IV x1
Amount of Postop Narcotic Usage	1 number of tablets Interval 1.0 to 2.0	2 number of tablets Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 24 hours

NRS scale 0-10 for nausea. Zero indicates no nausea, Ten indicates the worst nausea imagined.

Outcome measures

Outcome measures
Measure	Intervention n=41 Participants Dexamethasone 8mg iv x 1 Dexamethasone 8mg iv x1: Dexamethasone 8mg iv x1	Placebo n=41 Participants placebo placebo: placebo administered IV x1
Postop Nausea	0 units on a scale Interval 0.0 to 0.0	0 units on a scale Interval 0.0 to 1.0

Adverse Events

Intervention

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

Dr Lauren Fisher

Beth Israel Deaconess Medical Center

Phone: 6176671853

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place