A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval

Study Overview
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Brief Summary
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Current standard of care is no pretreatment medications before the egg retrieval, and the investigators would like to evaluate if preoperative Tylenol improves procedure and post procedure pain control over the current practice (no pre-treatment). Specifically, this study will compare Tylenol with a placebo when given before retrieval procedures. The investigators believe that if Tylenol can offer better analgesic relief than no pretreatment medications, then it may reduce the amount of narcotics needed by patients during and after the procedure and contribute to better patient satisfaction. . This study will enroll 100 participants all from University of Alabama at Birmingham (UAB).

Detailed Description
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The current standard of care for oocyte retrieval in IVF involves fentanyl, propofol, as well as oxycodone. However, there exists little data of alternatives to narcotic medications for analgesic purposes in oocyte retrieval procedures. A retrospective study published in 2013 showed potential for NSAID's, specifically ketorolac, to significantly improve pain scores in women undergoing oocyte retrieval. It was also shown that the use of these medications did not significantly alter pregnancy rate, live birth rate, or miscarriage rate in these patients. Few other studies have delved into the question of anesthetics for oocyte retrievals except a prospective study in 2006. This study shows that no significant difference in pregnancy rates of implantation occurs with the use of acetaminophen and diclofenac vs. acetaminophen alone if given post-operatively. However, pain was not measured in this study for either group. Therefore, it is clear that there exists limited data on the subject of analgesics used in oocyte retrievals for in vitro fertilization and that more exploration into alternative medications is required to find the most effective and least harmful option.

Official Title
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A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval

Conditions
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Pain

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English Speaking Undergoing Transvaginal Oocyte Retrieval Procedure Exclusion Criteria: Acetaminophen allergy Opioid dependency

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. | Drug: placebo<br>* subjects randomized to this group will be given placebo tablets<br>* Other names: sugar pill;|
| Experimental: Experimental<br>Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure. | Drug: Acetaminophen<br>* Acetaminophen total dose of 1000mg<br>* Other names: paracetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure | Median of cumulative pain scores (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken during the recovery period (15, 30, 45, and 60 minutes post procedure) | 60 minutes post-procedure | 
| Median of Cumulative Pain Scores Up to 24 Hours Post Procedure | Median Pain score (measured on a visual analog scale from 0-10 where 0=no pain and 10=worst pain) taken at 24-hours post-procedure | 24-hours post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure | Number of participants requiring use of analgesic medications in the post-operative recovery suite | 60-minutes post-procedure | 
| Number of Participants With Use of Analgesics in the First 24 Hours After Discharge | Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure | 60-minutes post-procedure to 24-hours after procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesic, Pain Control, IVF, Tylenol, Acetaminophen, Egg Retrieval, iv vitro Fertilization