Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

Not Applicable

Terminated

• Conditions: IVF; Postoperative Pain
• Interventions: Drug: acetaminophen

• Registration Number: NCT04662567
• Lead Sponsor: Northwell Health

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

Study Timeline

• Study First Submitted: 2020-11-16
• Study First Submitted QC: 2020-12-08
• Study First Posted: 2020-12-10
• Study Start: 2021-03-12
• Primary Completion: 2021-09-05
• Study Completion: 2021-09-05
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral acetaminophen group	acetaminophen	the subjects in this group will receive 1000 mg oral acetaminophen 30-45min prior to oocyte retrieval
IV acetaminophen group	acetaminophen	the subjects in this group will receive 1000 mg IV acetaminophen formulation intraoperatively

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Northwell Fertility Center #3816; 🇺🇸 Manhasset, New York, United States