Clinical trial NCT02418182: A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval
Official title: A Randomized Controlled Trial of Oral Acetaminophen for Analgesic Control After Transvaginal Oocyte Retrieval
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Analgesic
Pain Control
IVF
Tylenol
Acetaminophen
Egg Retrieval
iv vitro Fertilization
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-04-16
Enrollment: 99
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

* English Speaking
* Undergoing Transvaginal Oocyte Retrieval Procedure

Exclusion Criteria:

* Acetaminophen allergy
* Opioid dependency

Primary outcomes:
measure: Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure
timeFrame: 60 minutes post-procedure
measure: Median of Cumulative Pain Scores Up to 24 Hours Post Procedure
timeFrame: 24-hours post-procedure
Secondary outcomes:
measure: Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure
timeFrame: 60-minutes post-procedure
measure: Number of Participants With Use of Analgesics in the First 24 Hours After Discharge
timeFrame: 60-minutes post-procedure to 24-hours after procedure
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Deidre D Gunn, MD
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Deidre D Gunn, MD
role: PRINCIPAL_INVESTIGATOR
References: