Trial Outcomes & Findings for High vs Low Dose Dexamethasone on Complications in the Immediate Postoperative Phase (NCT NCT03161938)

NCT ID: NCT03161938

Last Updated: 2020-04-29

Results Overview

Moderate to severe pain (NRS \> 3) in the post-anesthesia care unit (PACU)

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 64 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2020-04-29

Participant Flow

Participant milestones

Measure	Dexamethasone 48 mg Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Overall Study STARTED	32	32
Overall Study COMPLETED	32	32
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

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous	Total n=64 Participants Total of all reporting groups
Age, Continuous	28 years STANDARD_DEVIATION 8 • n=32 Participants	29 years STANDARD_DEVIATION 7 • n=32 Participants	29 years STANDARD_DEVIATION 8 • n=64 Participants
Sex: Female, Male Female	27 Participants n=32 Participants	24 Participants n=32 Participants	51 Participants n=64 Participants
Sex: Female, Male Male	5 Participants n=32 Participants	8 Participants n=32 Participants	13 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body Mass Index (BMI)	23 kg/m^2 STANDARD_DEVIATION 3 • n=32 Participants	23 kg/m^2 STANDARD_DEVIATION 3 • n=32 Participants	23 kg/m^2 STANDARD_DEVIATION 3 • n=64 Participants
Previous operation (contralateral periacetabular osteotomy)	3 Participants n=32 Participants	9 Participants n=32 Participants	12 Participants n=64 Participants
Comorbidities, none	30 Participants n=32 Participants	27 Participants n=32 Participants	57 Participants n=64 Participants
Daily intake of analgesics, preoperative	4 Participants n=32 Participants	6 Participants n=32 Participants	10 Participants n=64 Participants
Daily intake of opioids, preoperative	2 Participants n=32 Participants	2 Participants n=32 Participants	4 Participants n=64 Participants
Operating time	71 minutes STANDARD_DEVIATION 20 • n=32 Participants	69 minutes STANDARD_DEVIATION 13 • n=32 Participants	70 minutes STANDARD_DEVIATION 17 • n=64 Participants
Bleeding	467 ml STANDARD_DEVIATION 301 • n=32 Participants	510 ml STANDARD_DEVIATION 295 • n=32 Participants	500 ml STANDARD_DEVIATION 296 • n=64 Participants

PRIMARY outcome

Timeframe: 12 hours

Moderate to severe pain (NRS > 3) in the post-anesthesia care unit (PACU)

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Number of Participants With Moderate to Severe Postoperative Pain	26 Participants	22 Participants

SECONDARY outcome

Timeframe: 24 hours

Total lenght of stay in PACU

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Lenght of Stay, PACU	2 hours Interval 2.0 to 3.0	3 hours Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: 1 week

Total lenght of stay, Hospital

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Lenght of Stay, Hospital	78 hours Interval 73.0 to 101.0	77 hours Interval 71.0 to 94.0

SECONDARY outcome

Timeframe: 12 hours

Differences between groups in maximal and average pain score during PACU stay. Pain scores are measured on a numeric rating scale (NRS), 0-10. 0 is no pain, 10 is worst pain imaginable.

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Pain Scores, PACU Maximal pain	5 score on a scale (numeric rating scale) Interval 3.0 to 7.0	5 score on a scale (numeric rating scale) Interval 3.0 to 7.0
Pain Scores, PACU Average pain	2 score on a scale (numeric rating scale) Interval 1.0 to 3.0	2 score on a scale (numeric rating scale) Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 24 hours

Patients with complications requiring treatment the first 24 hours (PACU and ward)

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Complications	24 Participants	25 Participants

SECONDARY outcome

Timeframe: postoperative day 0 to 4, once a day

Population: Missing data, missing at random

Self-reported pain on a Numeric rating scale (NRS), NRS 0-10, 0 = no pain, 10= worst pain imaginable.

Reported once daily, postoperative days 0 to 4

Outcome measures

Measure	Dexamethasone 48 mg n=26 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=25 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Self Reported Postoperative Pain Day 0	3 score on a scale Standard Deviation 2	4 score on a scale Standard Deviation 2
Self Reported Postoperative Pain Day 1	4 score on a scale Standard Deviation 2	4 score on a scale Standard Deviation 2
Self Reported Postoperative Pain Day 2	3 score on a scale Standard Deviation 2	4 score on a scale Standard Deviation 2
Self Reported Postoperative Pain Day 3	3 score on a scale Standard Deviation 2	3 score on a scale Standard Deviation 2
Self Reported Postoperative Pain Day 4	3 score on a scale Standard Deviation 2	3 score on a scale Standard Deviation 2

SECONDARY outcome

Timeframe: postoperative day 0 to 4, once a day

Population: Missing data day 4 due to discharge from hospital

Patients reporting PONV and/or receiving antiemetic medication on postoperative days 0 to 4

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4 Day 0	7 Participants	8 Participants
Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4 Day 1	6 Participants	9 Participants
Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4 Day 2	9 Participants	11 Participants
Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4 Day 3	7 Participants	4 Participants
Number of Patients With Post Operative Nausea and Vomiting (PONV) Postoperative Days 0 to 4 Day 4	3 Participants	2 Participants

SECONDARY outcome

Timeframe: 4 days

Population: Missing data from questionnaires, missing at random, not filled out or not sent back

Self-reported quality of sleep (days 0-4). Questionnaire. Results dichotomized to sleep problems (trouble falling asleep, frequent awakenings, no sleep) or no sleep problems.

Outcome measures

Measure	Dexamethasone 48 mg n=26 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=25 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Number of Patients With Sleep Problems Day 0	13 Participants	12 Participants
Number of Patients With Sleep Problems Day 1	9 Participants	13 Participants
Number of Patients With Sleep Problems Day 2	8 Participants	9 Participants
Number of Patients With Sleep Problems Day 3	9 Participants	9 Participants
Number of Patients With Sleep Problems Day 4	8 Participants	8 Participants

SECONDARY outcome

Timeframe: postoperative day 0 to 4, once a day

Population: Missing data from questionnaires, missing at random

Self-reported feelings of anxiety, unrest, sadness (days 0-4). Questionnaire

Outcome measures

Measure	Dexamethasone 48 mg n=26 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=25 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 0 : sadness	8 Participants	2 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 0 : restlessness	11 Participants	8 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 0 : fatigue	23 Participants	21 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 1 : sadness	6 Participants	4 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 1 : restlessness	3 Participants	8 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 1 : fatigue	20 Participants	17 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 2 : sadness	8 Participants	8 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 2 : restlessness	6 Participants	11 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 2 : fatigue	21 Participants	14 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 3 : sadness	9 Participants	6 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 3 : restlessness	9 Participants	8 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 3 : fatigue	17 Participants	13 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 4 : sadness	8 Participants	5 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 4 : restlessness	10 Participants	3 Participants
Number of Patients With Feelings of Anxiety, Unrest and/or Sadness Day 4 : fatigue	17 Participants	10 Participants

SECONDARY outcome

Timeframe: 30 days

Any readmission within 30 days

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Number of Patients Readmitted to Hospital Within 30 Days	1 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Any wound infections/complications

Outcome measures

Measure	Dexamethasone 48 mg n=32 Participants Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 Participants Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Number of Patients With Wound Infections Within 30 Days	0 Participants	0 Participants

Adverse Events

Dexamethasone 48 mg

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Dexamethasone 8 mg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dexamethasone 48 mg n=32 participants at risk Dexamethasone 48 mg pre-operative, single shot injection Dexamethasone: intravenous	Dexamethasone 8 mg n=32 participants at risk Dexamethasone 8 mg pre-operative, single shot injection Dexamethasone: intravenous
Surgical and medical procedures bleeding, intraoperative	3.1% 1/32 • Number of events 1 • 60 hours after administration of trial drug(collection of possible adverse drug reactions), for readmissions and woundinfections: 30 days.	0.00% 0/32 • 60 hours after administration of trial drug(collection of possible adverse drug reactions), for readmissions and woundinfections: 30 days.

Other adverse events

Adverse event data not reported

Additional Information

Kristin steinthorsdottir

Rigshospitalet

Phone: 31666112

Email: kjs@dadlnet.dk

Results disclosure agreements

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