IVF, Postoperative Pain
Conditions
Keywords
oocyte retrieval, postoperative pain control, in vitro fertilization, tylenol
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
Interventions
DRUGacetaminophen
compare the postoperative pain 1 hour and \ 24h post surgery
Sponsors
Northwell Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed