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Completed

NCT Number: NCT02418182

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

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).

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Key information

Conditions

Pain Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Deidre D Gunn, MD

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • English Speaking
  • Undergoing Transvaginal Oocyte Retrieval Procedure

Exclusion criteria

  • Acetaminophen allergy
  • Opioid dependency

Treatment and study plan

Acetaminophen

Drug

Acetaminophen total dose of 1000mg

Other names: Tylenol, paracetamol

Placebo

Drug

subjects randomized to this group will be given placebo tablets

Other names: sugar pill

Primary outcomes

  1. Median of Cumulative Pain Scores Up to 60 Minutes Post Procedure

    Time frame: 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)

  2. Median of Cumulative Pain Scores Up to 24 Hours Post Procedure

    Time frame: 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

Secondary outcomes

  1. Number of Participants With Use of Analgesics up to 60 Minutes Post Procedure

    Time frame: 60-minutes post-procedure

    Number of participants requiring use of analgesic medications in the post-operative recovery suite

  2. Number of Participants With Use of Analgesics in the First 24 Hours After Discharge

    Time frame: 60-minutes post-procedure to 24-hours after procedure

    Number of participants with use of analgesic medications in the first 24 hours after discharge from procedure

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2015
Registry last updated
Feb 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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