Trial Outcomes & Findings for Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval (NCT NCT03073980)

Last Updated: 2022-05-26

Results Overview

Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

161 participants

Primary outcome timeframe

Pain was measured pre-operatively and at 10 minutes post-procedure.

Results posted on

2022-05-26

Participant Flow

Participant milestones

Participant milestones
Measure	Group A: IV Acetaminophen/PO Placebo In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen	Group B: IV Placebo/PO Acetaminophen In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen	Group C: IV Placebo/ PO Placebo In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen
Overall Study STARTED	53	54	54
Overall Study COMPLETED	43	52	43
Overall Study NOT COMPLETED	10	2	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Group A: IV Acetaminophen/PO Placebo In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen	Group B: IV Placebo/PO Acetaminophen In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen	Group C: IV Placebo/ PO Placebo In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen
Overall Study Lost to Follow-up	10	2	9
Overall Study No post-procedure data	0	0	2

Baseline Characteristics

Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group A: IV Acetaminophen/PO Placebo n=53 Participants In the pre-op suite, these patients will receive 1000mg IV acetaminophen and PO placebo, followed by standard protocol anesthesia and pain control as needed. IV Acetaminophen: IV Acetaminophen for pain control during procedure Placebo PO Acetaminophen: Placebo PO Acetaminophen	Group B: IV Placebo/PO Acetaminophen n=54 Participants In the pre-op suite, these patients will receive 1000mg PO acetaminophen and IV placebo, followed by standard protocol anesthesia and pain control as needed. PO Acetaminophen: PO Acetaminophen for pain control during procedure Placebo IV Acetaminophen: Placebo IV Acetaminophen	Group C: IV Placebo / PO Placebo n=52 Participants In the pre-op suite, these patients will receive PO and IV placebo, followed by standard protocol anesthesia and pain control as needed. Placebo IV Acetaminophen: Placebo IV Acetaminophen Placebo PO Acetaminophen: Placebo PO Acetaminophen	Total n=159 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	53 Participants n=93 Participants	54 Participants n=4 Participants	52 Participants n=27 Participants	159 Participants n=483 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Continuous	35.2 years STANDARD_DEVIATION 4.1 • n=93 Participants	35.7 years STANDARD_DEVIATION 4.5 • n=4 Participants	36.0 years STANDARD_DEVIATION 4.0 • n=27 Participants	35.6 years STANDARD_DEVIATION 4.2 • n=483 Participants
Sex: Female, Male Female	53 Participants n=93 Participants	54 Participants n=4 Participants	52 Participants n=27 Participants	159 Participants n=483 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=93 Participants	1 Participants n=4 Participants	4 Participants n=27 Participants	8 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	7 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	48 Participants n=93 Participants	50 Participants n=4 Participants	46 Participants n=27 Participants	144 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants	15 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	2 Participants n=4 Participants	1 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) White	41 Participants n=93 Participants	43 Participants n=4 Participants	39 Participants n=27 Participants	123 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=93 Participants	5 Participants n=4 Participants	6 Participants n=27 Participants	16 Participants n=483 Participants
Region of Enrollment United States	53 participants n=93 Participants	54 participants n=4 Participants	52 participants n=27 Participants	159 participants n=483 Participants
Ovarian reserve (anti-mullerian hormone)	2.9 ng/ml STANDARD_DEVIATION 2.9 • n=93 Participants	3.0 ng/ml STANDARD_DEVIATION 2.4 • n=4 Participants	2.4 ng/ml STANDARD_DEVIATION 1.7 • n=27 Participants	2.8 ng/ml STANDARD_DEVIATION 2.3 • n=483 Participants
Number of Nulliparous Participants	41 Participants n=93 Participants	39 Participants n=4 Participants	43 Participants n=27 Participants	123 Participants n=483 Participants
Body Mass Index (BMI)	25.4 kg/m^2 STANDARD_DEVIATION 4.7 • n=93 Participants	24.9 kg/m^2 STANDARD_DEVIATION 4.1 • n=4 Participants	25.6 kg/m^2 STANDARD_DEVIATION 4.9 • n=27 Participants	25.3 kg/m^2 STANDARD_DEVIATION 4.6 • n=483 Participants

PRIMARY outcome

Timeframe: Pain was measured pre-operatively and at 10 minutes post-procedure.

Population: Post-operative pain score - pre-operative pain score; 2 patients in group 3 had egg retrieval cancelled due to Coronavirus Disease (COVID); data could not be collected in these patients, yet their enrollment was included in an intention-to-treat analysis.

Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score.