Toradol for Postoperative Pain After Egg Retrieval

(Alleviate Trial)

Recruiting at 1 trial location

Overseen By Tasha Newsome

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Shady Grove Fertility Reproductive Science Center

Must not be taking: Chronic opioids

Disqualifiers: Allergy to ketorolac, Substance abuse, others

Compensation: Varies

Number of Visits: 2

Duration: 1 day

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Kathleen Devine, MD

Principal Investigator

Shady Grove Fertility Reproductive Science Center

Are You a Good Fit for This Trial?

This trial is for women over 18 who are undergoing egg retrieval as part of IVF and can understand English or have a translator. It's not for those allergic to Ketorolac, with certain medical conditions like ulcers, bleeding disorders, severe liver/kidney disease, recent heart attacks/strokes, very high BMI (≥40), substance abuse history, or chronic opioid use.

Inclusion Criteria

Patients must be able to read and understand written English or have an appropriate certified medical translator available

Standard eligibility criteria to undergo IVF and embryo transfer at Shady Grove

Signed informed consent

Exclusion Criteria

You have a body mass index (BMI) of 40 or higher.

You have a history of using drugs or alcohol in a harmful way.

You have been using opioid medication for a long time.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval, followed by administration of either IV ketorolac or IV placebo

1 day

1 visit (in-person)

Immediate Post-operative

Participants are monitored for pain control and narcotic use in the immediate post-operative period

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain control and narcotic use after discharge

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ketorolac (Toradol)
• Placebo (saline)

Trial Overview The study tests if Ketorolac (Toradol), an anti-inflammatory drug, can better manage pain and reduce the need for narcotics after egg retrieval compared to a placebo (saline solution). Participants will be randomly assigned to receive either Ketorolac or the placebo.

How Is the Trial Designed?

Group I: Standard post-operative pain management + Ketorolac (Toradol) Experimental Treatment 1 Intervention

Subject will undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval. Standard protocols will be used for both study groups and involve administration of gonadotropins to stimulate ovarian follicle growth and regular monitoring with ultrasound and serum estradiol and progesterone levels until follicles reach a desired size. Human Chorionic Gonadotropin (HCG) or leuprolide acetate will be administered to trigger final oocyte maturation prior to oocyte retrieval under anesthesia. On the day of oocyte retrieval, the anesthesia provider will provide syringes of IV ketorolac (30 mg if ≥50 kg or 15 mg if \<50 kg per manufacturer dosing) or IV placebo (saline). If assigned to the study arm, IV ketorolac will be administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. Patients will be contacted post-operatively, to access pain scores and record the amount of the prescribed narcotic medications utilized since discharge.

Group II: Standard post-operative pain management + Placebo (saline) Placebo Group 1 Intervention

Subject will undergo an IVF cycle with ovarian hyperstimulation and oocyte retrieval. Standard protocols will be used for both study groups and involve administration of gonadotropins to stimulate ovarian follicle growth and regular monitoring with ultrasound and serum estradiol and progesterone levels until follicles reach a desired size. HCG or leuprolide acetate will be administered to trigger final oocyte maturation prior to oocyte retrieval under anesthesia. On the day of oocyte retrieval, the anesthesia provider will provide syringes of IV ketorolac (30 mg if ≥50 kg or 15 mg if \<50 kg per manufacturer dosing) or IV placebo (saline). If assigned to the control arm, IV placebo (saline) will be administered by the anesthesia provider. All enrolled patients will receive standard post-operative pain management. Patients will be contacted post-operatively, to access pain scores and record the amount of the prescribed narcotic medications utilized since discharge.

Who Is Running the Clinical Trial?

Shady Grove Fertility Reproductive Science Center

Lead Sponsor

Trials

7

Recruited

2,900+