Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

November 25, 2022 updated by: Northwell Health

Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial

The investigators are going to study the difference in postoperative pain control after administration of oral versus intravenous formulation of acetaminophen

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Oocyte retrieval is an outpatient procedure that is a routine surgical intervention in the process of assisted reproductive technologies and oocyte banking. The perioperative pain control is achieved with multidrug regimen including intraoperative opioid medication and perioperative administration of oral or intravenous acetaminophen. This medication is more commonly known as Tylenol. Intravenous formulation of this medication is several fold more expensive and the data for perioperative pain control is mixed on the equivalence of pain control with intravenous versus oral acetaminophen in other fields. Currently there is no accepted standard of care and the two formulations are used interchangeably depending on primary physician's preference. We are conducting an equivalence placebo controlled randomized clinical trial to assess the difference in efficacy of these two formulations

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Manhasset, New York, United States, 11030
        • Northwell Fertility Center #3816

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Provision of signed and dated informed consent form
  2. Stated willingness to comply with all study procedures and availability for the duration of the study
  3. Female, aged 18-45
  4. Ability to take oral medication and be willing to adhere to the study intervention regimen

Exclusion Criteria:

  1. Known clinically significant liver disfunction
  2. Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other
  3. Known current substance use disorder
  4. Chronic pain syndrome
  5. Weight less than 50 kg

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Oral acetaminophen group
the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval
Drug: acetaminophen
compare the postoperative pain 1 hour and ~24h post surgery
ACTIVE_COMPARATOR: IV acetaminophen group
the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively
Drug: acetaminophen
compare the postoperative pain 1 hour and ~24h post surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain control
Time Frame: 24-48 hours

To compare the efficacy of oral versus IV formulation of acetaminophen for controlling perioperative pain after oocyte retrieval procedure.

To assess the pain level, Visual Analog Scale(VAS) score will be utilize with the minimum number 0 representing no pain and maximum number of 10 representing the highest imaginable pain level.
24-48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of postoperative recovery
Time Frame: variable ~1-3 hours
To compare time from the end of procedure until discharge. This outcome is measured in minutes from the the time of entry to recovery room to the time when patient is leaving the facility
variable ~1-3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwell Health

Investigators

  • Principal Investigator: Christine Mullin, MD, Northwell Health OBGYN Infertility

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 12, 2021

Primary Completion (ACTUAL)

September 5, 2021

Study Completion (ACTUAL)

September 5, 2021

Study Registration Dates

First Submitted

November 16, 2020

First Submitted That Met QC Criteria

December 8, 2020

First Posted (ACTUAL)

December 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2022

Last Update Submitted That Met QC Criteria

November 25, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-1139

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

the individual participant data will not be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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