Pain, Postoperative Clinical Trial
Official title:
Assessing Efficacy of Intravenous Acetaminophen for Perioperative Pain Control for Oocyte Retrieval: a Randomized, Double Blind, Placebo-controlled Trial
Verified date | May 2022 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In this research study we want to learn more about how effective certain medications are at reducing pain after oocyte (egg) retrieval surgery and how effective they are at reducing the time between the retrieval and discharge from the hospital. We will compare three types of pre-operative medications: intravenous (IV) acetaminophen, oral (PO) acetaminophen, and placebo (no medication), which is the current typical care.
Status | Completed |
Enrollment | 161 |
Est. completion date | December 1, 2020 |
Est. primary completion date | November 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 44 Years |
Eligibility | Inclusion Criteria: [ ] Patient is 18 years or over, undergoing oocyte retrieval. [ ] Patient is English-speaking. Exclusion Criteria: [ ] Allergy/hypersensitivity to acetaminophen or opiates. [ ] Any history of liver disease, history of alcohol depending, or renal impairment as reported in the electronic health record. [ ] Any history chronic opiate use or chronic pain disorder reported in the electronic health record. [ ] Weight less than 50kg as reported in the medical record. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Post-operative Pain Score Difference 10 Mins From Pre-operative | Visual analog scale of pain, ranging from 0 (no pain) to 10 (worst pain imaginable) in whole numbers. The final score is the post-operative score minus the pre-operative score. | Pain was measured pre-operatively and at 10 minutes post-procedure. | |
Primary | Time to Discharge From the Post-operative Recovery Room | Discharge time was based on the nurse's assessment of patient alertness, ability to tolerate oral liquids and food, and ability to void. | 0-6 hours post-procedure | |
Secondary | Procedure Length | Duration of egg retrieval | 0-2 hours | |
Secondary | Postoperative Nausea and Vomiting | One or more episodes of nausea and vomiting in the recovery room and through post-operative day 2 | 0-2 days | |
Secondary | Oocyte Yield | The number of oocytes retrieved from the patient's ovaries as part of an in vitro-fertilization treatment. This includes both immature and mature oocytes. | 0 days | |
Secondary | Rescue Medication Required | One or more doses of opiate pain medication given due to pain during the procedure or immediately post-operative in the recovery room. | During procedure and immediately post-operative in recovery room within 45 minutes |
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