NCT03073980

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

Completed Phase 4 Results posted Last updated 26 May 2022

What this trial tests

Phase 4 trial testing IV Acetaminophen in Infertility, Female in 161 participants. Completed in 1 December 2020.

Timeline

1 September 2019

Primary endpoint
1 November 2020

1 December 2020

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	161
Start date	1 September 2019
Primary completion	1 November 2020
Estimated completion	1 December 2020
Sites	1 location across United States

Drugs / interventions tested

• IV Acetaminophen — full drug profile →
• PO Acetaminophen — full drug profile →
• Placebo IV Acetaminophen
• Placebo PO Acetaminophen

Conditions studied

• Infertility, Female — all drugs for Infertility, Female →
• Pain, Postoperative — all drugs for Pain, Postoperative →

Sponsor

Massachusetts General Hospital

Who can join

Adults 18 to 44, female only, with Infertility, Female or Pain, Postoperative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Post-operative Pain Score Difference 10 Mins From Pre-operative Primary · Pain was measured pre-operatively and at 10 minutes post-procedure.

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.

Group	Value	95% CI
Group 1: IV Acetaminophen/PO Placebo	1.3	± 2.4
Group 2: IV Placebo/PO Acetaminophen	1.3	± 2.8
Group 3: IV Placebo/PO Placebo	1.8	± 1.8

Time to Discharge From the Post-operative Recovery Room Primary · 0-6 hours post-procedure

Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void.

Group	Value	95% CI
Group 1: IV Acetaminophen/PO Placebo	60.1	± 22.0
Group 2: IV Placebo/PO Acetaminophen	58.8	± 17.0
Group 3: Placebo / Standard of Care	57.6	± 10.7

Procedure Length Secondary · 0-2 hours

Duration of egg retrieval

Group	Value	95% CI
Group A: IV Acetaminophen/PO Placebo	13.5	± 5.9
Group B: IV Placebo/PO Acetaminophen	13.7	± 5.3
Group C: IV Placebo/ PO Placebo	14.1	± 6.6

Postoperative Nausea and Vomiting Secondary · 0-2 days

One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2

Group	Value	95% CI
Group A: IV Acetaminophen/PO Placebo	3
Group B: IV Placebo/PO Acetaminophen	4
Group C: IV Placebo/ PO Placebo	2

Oocyte Yield Secondary · 0 days

The number of oocytes retrieved from the patient's ovaries as part of an in vitro-fertilization treatment. This includes both immature and mature oocytes.

Group	Value	95% CI
Group A: IV Acetaminophen/PO Placebo	12.6	± 8.8
Group B: IV Placebo/PO Acetaminophen	13.4	± 8.7
Group C: IV Placebo/ PO Placebo	11.4	± 5.9

Rescue Medication Required Secondary · During procedure and immediately post-operative in recovery room within 45 minutes

One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room.

Group	Value	95% CI
Group A: IV Acetaminophen/PO Placebo	4
Group B: IV Placebo/PO Acetaminophen	10
Group C: IV Placebo/ PO Placebo	8

Sponsor's own description

In this research study we want to learn more about how effective certain medications are at reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the time between the retrieval and discharge from the hospital. We will compare three types of pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and placebo (no medication), which is the current typical care.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Assessing efficacy of intravenous acetaminophen for perioperative pain control for oocyte retrieval: a randomized, double-blind, placebo-controlled trial.
   Sacha CR, Mortimer R, Hariton E, James K, et al · · 2022 · cited 5× · PMID 34548165 · DOI 10.1016/j.fertnstert.2021.08.046