Trial Outcomes & Findings for A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval (NCT NCT02418182)

Results Overview

Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure)

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

99 participants

Primary outcome timeframe

60 minutes post-procedure

Results posted on

2020-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	Control Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Overall Study STARTED	49	50
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	18	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Overall Study Unable to re-consent	18	15
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control n=31 Participants Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental n=33 Participants Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg	Total n=64 Participants Total of all reporting groups
Age, Continuous	33 years STANDARD_DEVIATION 4.4 • n=31 Participants	32 years STANDARD_DEVIATION 5.0 • n=33 Participants	32.5 years STANDARD_DEVIATION 4.7 • n=64 Participants
Sex: Female, Male Female	31 Participants n=31 Participants	33 Participants n=33 Participants	64 Participants n=64 Participants
Sex: Female, Male Male	0 Participants n=31 Participants	0 Participants n=33 Participants	0 Participants n=64 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	31 participants n=31 Participants	33 participants n=33 Participants	64 participants n=64 Participants

PRIMARY outcome

Timeframe: 60 minutes post-procedure

Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.

Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure)

Outcome measures

Outcome measures
Measure	Control n=31 Participants Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental n=33 Participants Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure	2 score on a scale Interval 0.0 to 3.0	2 score on a scale Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: 24-hours post-procedure

Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.

Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure

Outcome measures

Outcome measures
Measure	Control n=31 Participants Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental n=33 Participants Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Median of Cumulative Pain Scores Up to 24 Hours Post Procedure	1 score on a scale Interval 0.0 to 2.0	2 score on a scale Interval 0.0 to 3.0

SECONDARY outcome

Timeframe: 60-minutes post-procedure

Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.

Number of participants requiring use of analgesic medications in the post-operative recovery suite

Outcome measures

Outcome measures
Measure	Control n=31 Participants Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental n=33 Participants Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure	11 Participants	18 Participants

SECONDARY outcome

Timeframe: 60-minutes post-procedure to 24-hours after procedure

Population: Of 99 patients enrolled, 72 required re-consent. Of these, 39 re-consented and 33 could not be re-consented. Therefore, these 33 were excluded, leaving 66 patients for analysis. Two of these were lost to follow-up and were excluded, leaving 64 women (31 control, 33 active arm) in the final analysis.

Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure

Outcome measures

Outcome measures
Measure	Control n=31 Participants Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental n=33 Participants Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Number of Participants With Use of Analgesics in the First 24 Hours After Discharge	25 Participants	27 Participants

Adverse Events

Control

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Experimental

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Control n=31 participants at risk Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. placebo: subjects randomized to this group will be given placebo tablets	Experimental n=33 participants at risk Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. Acetaminophen: Acetaminophen total dose of 1000mg
Gastrointestinal disorders Nausea/Vomiting	12.9% 4/31 • Number of events 4 • Each participant was measured from baseline through 24 hours post-procedure.	27.3% 9/33 • Number of events 9 • Each participant was measured from baseline through 24 hours post-procedure.

Additional Information

Deidre Gunn, Assistant Professor

University of Alabama at Birmingham

Phone: 205-934-1030

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place