Oral Versus Intravenous Acetaminophen for Postoperative Pain Control

Northwell Health

Status: Terminated

Conditions: Postoperative Pain; IVF

Treatments: Drug: acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT04662567

20-1139

Details and patient eligibility

About

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

Full 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

Enrollment: 42 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups

Oral acetaminophen group

Active Comparator group

Description:

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

Treatment:

Drug: acetaminophen

IV acetaminophen group

Active Comparator group

Description:

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

Treatment:

Drug: acetaminophen