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Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

Primary Purpose

Postoperative Pain, IVF

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acetaminophen
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Pain focused on measuring oocyte retrieval, postoperative pain control, in vitro fertilization, tylenol

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Northwell Fertility Center #3816

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Oral acetaminophen group

IV acetaminophen group

Arm Description

the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval

the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively

Outcomes

Primary Outcome Measures

postoperative pain control
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

Duration of postoperative recovery
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

Full Information

First Posted
November 16, 2020
Last Updated
November 25, 2022
Sponsor
Northwell Health
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1. Study Identification

Unique Protocol Identification Number
NCT04662567
Brief Title
Oral Versus Intravenous Acetaminophen for Postoperative Pain Control
Official Title
Oral Versus Intravenous Acetaminophen for Postoperative Pain Management After Oocyte Retrieval Procedure. A Double Blinded, Placebo Controlled, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
It was determined that the study should not continue as the study drug, Acetaminophen, could only be mixed in a solvent that would not allow the patients to be NPO prior to procedure.
Study Start Date
March 12, 2021 (Actual)
Primary Completion Date
September 5, 2021 (Actual)
Study Completion Date
September 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, IVF
Keywords
oocyte retrieval, postoperative pain control, in vitro fertilization, tylenol

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral acetaminophen group
Arm Type
Active Comparator
Arm Description
the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval
Arm Title
IV acetaminophen group
Arm Type
Active Comparator
Arm Description
the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively
Intervention Type
Drug
Intervention Name(s)
acetaminophen
Intervention Description
compare the postoperative pain 1 hour and ~24h post surgery
Primary Outcome Measure Information:
Title
postoperative pain control
Description
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.
Time Frame
24-48 hours
Secondary Outcome Measure Information:
Title
Duration of postoperative recovery
Description
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
Time Frame
variable ~1-3 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of signed and dated informed consent form Stated willingness to comply with all study procedures and availability for the duration of the study Female, aged 18-45 Ability to take oral medication and be willing to adhere to the study intervention regimen Exclusion Criteria: Known clinically significant liver disfunction Known allergic reactions to components of acetaminophen such as angioedema, anaphylaxis or other Known current substance use disorder Chronic pain syndrome Weight less than 50 kg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Mullin, MD
Organizational Affiliation
Northwell Health OBGYN Infertility
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwell Fertility Center #3816
City
Manhasset
State/Province
New York
ZIP/Postal Code
11030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
the individual participant data will not be shared
Citations:
PubMed Identifier
12044794
Citation
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Results Reference
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Citation
Flower RJ, Vane JR. Inhibition of prostaglandin synthetase in brain explains the anti-pyretic activity of paracetamol (4-acetamidophenol). Nature. 1972 Dec 15;240(5381):410-1. doi: 10.1038/240410a0. No abstract available.
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PubMed Identifier
15662292
Citation
Graham GG, Scott KF. Mechanism of action of paracetamol. Am J Ther. 2005 Jan-Feb;12(1):46-55. doi: 10.1097/00045391-200501000-00008.
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Hinz B, Brune K. Paracetamol and cyclooxygenase inhibition: is there a cause for concern? Ann Rheum Dis. 2012 Jan;71(1):20-5. doi: 10.1136/ard.2011.200087. Epub 2011 Oct 28.
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PubMed Identifier
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Results Reference
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PubMed Identifier
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Citation
Jahr JS, Lee VK. Intravenous acetaminophen. Anesthesiol Clin. 2010 Dec;28(4):619-45. doi: 10.1016/j.anclin.2010.08.006.
Results Reference
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PubMed Identifier
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Citation
Moller PL, Sindet-Pedersen S, Petersen CT, Juhl GI, Dillenschneider A, Skoglund LA. Onset of acetaminophen analgesia: comparison of oral and intravenous routes after third molar surgery. Br J Anaesth. 2005 May;94(5):642-8. doi: 10.1093/bja/aei109. Epub 2005 Mar 24.
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Citation
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Citation
Pickering G, Esteve V, Loriot MA, Eschalier A, Dubray C. Acetaminophen reinforces descending inhibitory pain pathways. Clin Pharmacol Ther. 2008 Jul;84(1):47-51. doi: 10.1038/sj.clpt.6100403. Epub 2007 Oct 24.
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Citation
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Results Reference
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Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

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