Assessing Ketorolac (Toradol) at Oocyte Retrieval

Shady Grove Fertility Reproductive Science Center400 enrolled

Overview

To determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval.

Postoperative pain control is an essential component to any surgical procedure. Surgery represents a time during which opioid-naïve patients may be exposed to narcotics, risking opioid related complications and future opioid-use disorder. Approximately 150,000 oocyte retrievals are performed per year in the United States, according to the 2017 Assisted Reproductive Technology National Summary Report. A reduction in exposure to narcotics in this field has significant public health implications, particularly given that approximately 6% of new persistent opioid use occurs following minor surgical procedures. Ketorolac (Toradol) has been demonstrated to be a safe and efficacious agent to achieve pain control postoperatively with no significant increase in adverse events. The purpose of this prospective randomized blinded placebo controlled trial is to determine if a nonsteroidal anti-inflammatory drug (NSAID), Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval. Approximately 400 women (n=200 in each arm) will be enrolled according to the inclusion/exclusion criteria among patients of Shady Grove Fertility. Participants will undergo a standard in vitro fertilization cycle (IVF) followed by egg retrieval (ER). Participants will be randomized to receive either IV ketorolac or IV placebo at the conclusion of the egg retrieval, administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. The investigational component of this study lies in assessing post-operative pain control in the immediate post-operative period and in the post-operative period after discharge as reflected by pain scores and narcotic medication usage.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

400

Conditions

Infertility Infertility, Female Oocyte Retrieval Postoperative Pain Embryo Transfer

Interventions

Ketorolac (Toradol)DRUG

IV Ketorolac (Toradol) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.

Placebo (saline)OTHER

IV Placebo (saline) will be administered at conclusion of oocyte retrieval. All enrolled patients will receive standard post-operative pain management.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Signed informed consent 2. Females over 18 years of age who are scheduled to undergo oocyte retrieval 3. Patients must be able to read and understand written English or have an appropriate certified medical translator available. 4. Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove Exclusion Criteria: 1. Known allergy to ketorolac 2. Those with known medical conditions precluding them from ketorolac use (active peptic ulcer disease, recent or history of hemorrhage or perforation, known renal or hepatic insufficiency, suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, bleeding disorders, recent myocardial infarction, or stroke.) 3. BMI ≥ 40 kg/m2 4. History of substance abuse 5. Chronic opioid use 6. Transabdominal oocyte retrieval

Locations (2)

Shady Grove Fertility Reproductive Science Center

Rockville, Maryland, United States

RECRUITING

Shady Grove Fertility Reproductive Science Center

Fairfax, Virginia, United States

RECRUITING

Outcomes

Primary Outcomes

Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)

The primary objective is to evaluate the use of ketorolac as a safe and effective analgesic after transvaginal oocyte retrieval (TVOR) by assessing the number of patients requiring additional analgesia with IV narcotic during recovery in the post anesthesia care unit (PACU).