Clinical trial NCT06026553: Assessing Ketorolac (Toradol) at Oocyte Retrieval
Official title: A Randomized Blinded Placebo Controlled Trial Assessing Ketorolac (Toradol) at Oocyte Retrieval
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Infertility
Infertility, Female
Oocyte Retrieval
Postoperative Pain
Embryo Transfer
Keywords: Infertility, Female
In Vitro Fertilization
IVF
Oocyte Retrieval
Postoperative Pain Control
NSAID
Ketorolac
Non-Narcotic Analgesia
Lead sponsor: Shady Grove Fertility Reproductive Science Center
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Administration of IV narcotic for rescue analgesia during recovery in the post anesthesia care unit (PACU)
timeFrame: Oocyte retrieval procedure day
Secondary outcomes:
measure: Dose of narcotic for rescue analgesia during recovery in the PACU
timeFrame: Oocyte retrieval procedure day
measure: Type of narcotic for rescue analgesia during recovery in the PACU
timeFrame: Oocyte retrieval procedure day
measure: Intensity of pain at baseline
timeFrame: Oocyte retrieval procedure day
measure: Intensity of pain in PACU
timeFrame: Oocyte retrieval procedure day
measure: Intensity of pain after discharge
timeFrame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
measure: Home narcotic use
timeFrame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
measure: Incidence of complications and adverse events
timeFrame: From oocyte retrieval procedure day up to 1 week post oocyte retrieval
measure: Biochemical pregnancy rate for patients who proceed to a fresh embryo transfer.
timeFrame: From date of randomization until ~10 days following embryo transfer
measure: Clinical pregnancy rate for patients who proceed to a fresh embryo transfer.
timeFrame: From date of randomization until 5-8 weeks estimated gestational age
measure: Implantation rate for patients who proceed to a fresh embryo transfer.
timeFrame: From date of randomization until 7-8 weeks estimated gestational age
measure: Ongoing implantation rate for patients who proceed to a fresh embryo transfer.
timeFrame: From date of randomization until 7-8 weeks estimated gestational age
measure: Pregnancy loss rate for patients who proceed to a fresh embryo transfer.
timeFrame: From date of randomization until pregnancy loss, assessed up to 11 months
measure: Live birth rate for patients who proceed to a fresh embryo transfer.
timeFrame: From date of randomization until live born infant at an estimated gestational age of at least 23 weeks or greater, assessed up to 11 months
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Shady Grove Fertility Reproductive Science Center
state: Maryland
city: Fairfax
country: United States
facility: Shady Grove Fertility Reproductive Science Center
state: Virginia
Study officials:
affiliation: Shady Grove Fertility Reproductive Science Center
name: Kathleen Devine, MD
role: PRINCIPAL_INVESTIGATOR
References:
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