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Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

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ClinicalTrials.gov Identifier: NCT04662567
Recruitment Status : Suspended (Study on pause)
First Posted : December 10, 2020
Last Update Posted : July 9, 2021
Sponsor:
Information provided by (Responsible Party):
Northwell Health

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

Condition or disease Intervention/treatment Phase
Postoperative Pain IVF Drug: acetaminophen Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial
Actual Study Start Date : March 12, 2021
Estimated Primary Completion Date : May 30, 2022
Estimated Study Completion Date : December 31, 2022

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04662567


Locations
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United States, New York
Northwell Fertility Center #3816
Manhasset, New York, United States, 11030
Sponsors and Collaborators
Northwell Health
Investigators
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Principal Investigator: Christine Mullin, MD Northwell Health OBGYN Infertility
More Information
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Publications:

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Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT04662567    
Other Study ID Numbers: 20-1139
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: July 9, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: the individual participant data will not be shared

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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
Keywords provided by Northwell Health:
oocyte retrieval
postoperative pain control
in vitro fertilization
tylenol
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Acetaminophen
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics