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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418182
• Other study ID #: F141003005
• Status: Completed
• Phase: Phase 4
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: February 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

Inclusion Criteria:

• English Speaking

• Undergoing Transvaginal Oocyte Retrieval Procedure

Exclusion Criteria:

• Acetaminophen allergy

• Opioid dependency

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Acetaminophen
Acetaminophen total dose of 1000mg
• placebo
subjects randomized to this group will be given placebo tablets

Locations

Country	Name	City	State
United States	Deidre D Gunn, MD	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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