Toradol for Postoperative Pain After Egg Retrieval

(Alleviate Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Toradol, a nonsteroidal anti-inflammatory drug (NSAID), can manage pain and reduce the need for narcotics after egg retrieval. Participants will receive either Toradol or a placebo (a harmless substance with no active drug) alongside standard pain management. It is suitable for women scheduled for egg retrieval who do not have certain health conditions, such as peptic ulcers or kidney issues, and who do not use opioids regularly. The study will assess Toradol's effectiveness in easing post-procedure pain. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to explore its potential benefits.

Do I need to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you have a known medical condition that prevents you from using ketorolac, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that ketorolac, also known as Toradol, is well-tolerated for pain relief after egg retrieval. Studies indicate it can safely reduce the need for stronger pain medications by over 50%. In a trial with 400 patients, ketorolac proved to be a safe and effective painkiller after egg retrieval. Another study found no negative effects on pregnancy outcomes when ketorolac was used. Overall, evidence suggests that ketorolac is a safe option for managing pain after the procedure. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using ketorolac (Toradol) for postoperative pain after egg retrieval because it offers a non-narcotic option for pain management. Unlike standard care options that often rely on opioid painkillers, ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that targets inflammation and pain without the risk of addiction. Additionally, ketorolac is administered intravenously, allowing for rapid pain relief, which could be particularly beneficial after procedures like egg retrieval where quick recovery is desired. This approach could potentially reduce the need for opioid medications, leading to fewer side effects and a safer recovery process for patients.

What evidence suggests that Ketorolac (Toradol) might be an effective treatment for postoperative pain after egg retrieval?

Research has shown that using ketorolac (Toradol), which participants in this trial may receive, during egg retrieval can reduce the need for strong pain medications like opioids without affecting pregnancy outcomes. One study found that ketorolac effectively eases pain during this procedure. Another study noted that it might lower opioid use after the procedure, aiding recovery. Although researchers are still determining the best dose, ketorolac appears to be a safe and effective way to manage pain after egg retrieval. These findings suggest that ketorolac could enhance standard pain management methods. Participants in this trial will receive either ketorolac or a placebo (saline) for post-operative pain management. ^{1 2 5 6 7}

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 history of using drugs or alcohol in a harmful way.

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

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8267402/

Routine ketorolac at oocyte retrieval decreases ... Routine use of ketorolac at the time of oocyte retrieval may decrease the rate of postoperative opioid use without adversely impacting pregnancy and ...

2. fertstert.org fertstert.org/article/S0015-0282(23)00446-6/fulltext

KETOROLAC DOSE DID NOT AFFECT PAIN SCORES ... The lowest effective dose of ketorolac that achieves maximum analgesia during egg retrievals is unclear. There is minimal data on the impact of ketorolac on ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07185724

Ketorolac Use and Fresh Embryo Transfer Outcomes Secondary outcomes will include pain scale, narcotics required, time to discharge, need for evaluation w/in 24 hours for pain/bleeding, clinical pregnancy rates ...

4. medpagetoday.com medpagetoday.com/meetingcoverage/asrm/118267

NSAID Infusion Eases Pain of Egg Retrieval, Cuts Narcotic ... The trial sought to evaluate whether ketorolac is a safe and effective analgesic after transvaginal oocyte retrieval. A total of 400 patients ...

5. trialx.com trialx.com/clinical-trials/listings/250728/assessing-ketorolac-toradol-at-oocyte-retrieval/

Assessing Ketorolac (Toradol) at Oocyte Retrieval - Infertility ... Ketorolac (Toradol), can improve pain control and decrease narcotic use after undergoing egg retrieval. Approximately 400 women (n=200 in ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8267400/

Ketorolac use after oocyte retrieval: doing our part to ... Pregnancy outcomes were reported between patients receiving and not receiving ketorolac at the time of oocyte retrieval, with no differences observed between ...

7. fertstert.org fertstert.org/article/S0015-0282(13)00562-1/fulltext

The effect of ketorolac on pregnancy rates when used ... This study suggests ketorolac has no apparent detrimental effect on IVF pregnancy outcomes when administered immediately after oocyte retrieval. Ketorolac ...