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Toradol for Postoperative Pain After Egg Retrieval (Alleviate Trial)

Phase 1

Recruiting

Led By Kathleen Devine, MD

Research Sponsored by Shady Grove Fertility Reproductive Science Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females over 18 years of age who are scheduled to undergo oocyte retrieval

Be between 18 and 65 years old

Must not have

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)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 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

Summary

This trial tests if Toradol can reduce pain after egg retrieval and decrease need for painkillers.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ketorolac may cause side effects such as stomach pain/ulcers, bleeding problems including nosebleeds and heavy menstrual periods, headaches/dizziness/fatigue; kidney issues; swelling due to fluid retention; increased blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a woman over 18 scheduled for egg retrieval.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have conditions that prevent me from using ketorolac.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Biochemical pregnancy rate for patients who proceed to a fresh embryo transfer.

Clinical pregnancy rate for patients who proceed to a fresh embryo transfer.

Dose of narcotic for rescue analgesia during recovery in the PACU

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Standard post-operative pain management + Ketorolac (Toradol)Experimental Treatment1 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 Group1 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.

0 / 2Eligibility criteria met