Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

Sponsor

Northwell Health (Other)

Overall Status

Suspended

CT.gov ID

NCT04662567

Collaborator

(none)

482

Enrollment

Location

Arms

21.7

Anticipated Duration (Months)

22.3

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain IVF	Drug: acetaminophen	N/A

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

Study Type:

Interventional

Anticipated 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 :

Mar 12, 2021

Anticipated Primary Completion Date :

May 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Primary Outcome Measures

postoperative pain control [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

Duration of postoperative recovery [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

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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