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

NCT02418182 | Completed Phase 4 Results

• 1 other identifier: F141003005
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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).

Conditions

Pain

Keywords

Analgesic; Pain Control; IVF; Tylenol; Acetaminophen; Egg Retrieval; iv vitro Fertilization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

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

  60-minutes post-procedure

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

  60-minutes post-procedure to 24-hours after procedure

Study Arms (2)

Control

PLACEBO COMPARATOR

Control group participants will receive unlabelled 2 non-active placebo tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.

Drug: placebo

Experimental

EXPERIMENTAL

Experimental group participants will receive 2 acetaminophen 500mg tablets approximately 1 hour prior to transvaginal oocyte retrieval procedure.

Drug: Acetaminophen

Interventions

Acetaminophen DRUG

Acetaminophen total dose of 1000mg

Also known as: Tylenol, paracetamol

Experimental

placebo DRUG

subjects randomized to this group will be given placebo tablets

Also known as: sugar pill

Control

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• English Speaking
• Undergoing Transvaginal Oocyte Retrieval Procedure

You may not qualify if:

• Acetaminophen allergy
• Opioid dependency

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

Deidre D Gunn, MD

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Acetaminophen; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Carbohydrates

Results Point of Contact

• Title: Deidre Gunn, Assistant Professor
• Organization: University of Alabama at Birmingham

ddowns@uabmc.edu

205-934-1030

Study Officials

• Deidre D Gunn, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 13, 2015
• First Posted: April 16, 2015
• Study Start: January 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 18, 2020
• Results First Posted: February 18, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: To Be Determined
• Access Criteria: Shared through CT.gov

Locations

US (1)