Toradol for Postoperative Pain After Egg Retrieval

(Alleviate Trial)

Recruiting at 1 trial location

Overseen by Kathleen Devine, MD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Shady Grove Fertility Reproductive Science Center

Trial Summary

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.

Research Team

Kathleen Devine, MD

Principal Investigator

Shady Grove Fertility Reproductive Science Center

Eligibility Criteria

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

I am a woman over 18 scheduled for egg retrieval.

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

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.

Treatment Details

Interventions

• Ketorolac (Toradol) (Nonsteroidal Anti-inflammatory Drug)
• Placebo (saline) (Other)

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.

Participant Groups

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+