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Toradol for Postoperative Pain After Egg Retrieval (Alleviate Trial)

Q: Am I able to take part in this investigation?

In order to join this research, prospective patients must have fertility issues and be between 18 and 45 years old. Up to 400 volunteers are needed for the experiment.

Q: Is the upper age limit of this clinical experiment accommodating those beyond 55 years?

This clinical trial's parameters for enrollment demand that participants are between 18 and 45 years old.

Q: What is the current participation rate of this clinical experiment?

Affirmative. The clinicaltrials.gov database displays that this study, which was initially uploaded on 8/10/2022, is actively accepting patients. 400 participants need to be enrolled from 2 sites.

Q: Does the combination of standard post-operative pain management and Ketorolac (Toradol) present any potential risks for patients?

Taking into consideration the fact that this is a Phase 1 study, with limited evidence of safety and efficacy, our team at Power estimates Standard post-operative <a href="https://www.withpower.com/clinical-trials/pain-management">pain management</a> + Ketorolac (Toradol) to have a risk score of 1.

Q: Are there any openings for participants in this therapeutic experiment?

Affirmative. Clinicaltrials.gov contains evidence that this clinical trial is presently recruiting participants, having first been advertised on August 10th 2022 and recently revised on the 30th of August in 2023. This study seeks to enlist 400 individuals between 2 different sites.

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

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

Awards & highlights

Alleviate Trial 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.Check my eligibility

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.See study design

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.

Alleviate Trial 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.

Alleviate Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Alleviate 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Shady Grove Fertility Reproductive Science CenterLead Sponsor

6 Previous Clinical Trials

2,519 Total Patients Enrolled

Kathleen Devine, MDPrincipal InvestigatorShady Grove Fertility Reproductive Science Center

1 Previous Clinical Trials

800 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I able to take part in this investigation?

"In order to join this research, prospective patients must have fertility issues and be between 18 and 45 years old. Up to 400 volunteers are needed for the experiment."

Answered by AI

Is the upper age limit of this clinical experiment accommodating those beyond 55 years?

"This clinical trial's parameters for enrollment demand that participants are between 18 and 45 years old."

Answered by AI

What is the current participation rate of this clinical experiment?

"Affirmative. The clinicaltrials.gov database displays that this study, which was initially uploaded on 8/10/2022, is actively accepting patients. 400 participants need to be enrolled from 2 sites."

Answered by AI

Does the combination of standard post-operative pain management and Ketorolac (Toradol) present any potential risks for patients?

"Taking into consideration the fact that this is a Phase 1 study, with limited evidence of safety and efficacy, our team at Power estimates Standard post-operative pain management + Ketorolac (Toradol) to have a risk score of 1."

Answered by AI

Are there any openings for participants in this therapeutic experiment?

"Affirmative. Clinicaltrials.gov contains evidence that this clinical trial is presently recruiting participants, having first been advertised on August 10th 2022 and recently revised on the 30th of August in 2023. This study seeks to enlist 400 individuals between 2 different sites."

Answered by AI

Recent research and studies

Plastic and Reconstructive SurgeryJournal

Ketorolac Does Not Increase Perioperative Bleeding

Gobble, Ryan M., Han L. T. Hoang, Bart Kachniarz, and Dennis P. Orgill. 2014. “Ketorolac Does Not Increase Perioperative Bleeding”. Plastic and Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/01.prs.0000438459.60474.b5.

clinicaltrials.govStudy

Assessing Ketorolac (Toradol) at Oocyte Retrieval

2022. "Assessing Ketorolac (Toradol) at Oocyte Retrieval". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06026553.

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