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Nonsteroidal Anti-inflammatory Drug

15mg IV Ketorolac for Pain relief

Q: Is the inclusion criteria for this research study limited to individuals who are above 30 years old?

To be eligible for this clinical investigation, individuals must satisfy the age criterion of being at least 18 years old and not exceeding 65 years.

Q: What is the current number of individuals being recruited for participation in this clinical research study?

Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking participants. The study was initially posted on December 21st, 2023 and was most recently updated on the same date. The trial aims to enroll a total of 200 participants from a single location.

Q: Are potential participants currently able to apply for enrollment in this trial?

Indeed, the details on clinicaltrials.gov indicate that this particular trial is currently in search of eligible individuals. The initial posting for this clinical trial took place on December 21st, 2023 and the most recent update was made on the same day. The study aims to recruit a total of 200 participants from a single location.

Q: Who meets the criteria to participate in this medical study?

This clinical study aims to include 200 individuals seeking <a href="https://www.withpower.com/clinical-trials/pain">pain</a> relief, aged between 18 and 65 years. Notably, eligible participants should meet the following requirements: Adults visiting an emergency department who are below the age of 65, experiencing flank pain as their primary complaint, reporting a numerical rating scale (NRS) pain score of equal to or greater than 4 out of 10, and having determined treatment with intravenous ketorolac.

Q: Has the United States Food and Drug Administration given their approval for intravenous administration of ketorolac at a dosage of 15 milligrams?

Based on our assessment at Power, the safety rating for 15mg IV Ketorolac is a solid 3. This determination is influenced by the fact that this trial falls under Phase 4, indicating that the treatment has already received approval.

Phase 4

Recruiting

Led By Biren Bhatt, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

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

Must have

Pain score of 4 or greater on the 0-10 NRS

Adult emergency department patients < 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 180 minutes from medication administration

Awards & highlights

Study Summary

This trial is studying the effects of two different doses of a medication called ketorolac in patients with suspected kidney stone pain. They want to see how long the medication can provide pain relief in the

Who is the study for?

This trial is for adults under 65 who visit the emergency department with flank pain, have a pain score of at least 4 on the NRS scale, and are determined to need IV ketorolac treatment. It's specifically aimed at those suspected to have renal colic from kidney stones.Check my eligibility

What is being tested?

The study is testing two different doses of Ketorolac (15mg vs. 30mg) given intravenously to see which provides longer-lasting pain relief for patients with suspected renal colic in the emergency department setting.See study design

What are the potential side effects?

Ketorolac can cause side effects like stomach upset or ulcers, bleeding problems, kidney issues, dizziness, and headaches. The risk may vary depending on the dose received.

Eligibility Criteria

Inclusion Criteria

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

Select...

My pain level is 4 or higher on a scale of 0 to 10.

Select...

I am under 65 and was an emergency department patient.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 180 minutes from medication administration

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 180 minutes from medication administration

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 180 minutes from medication administration for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in pain scale post ketorolac administration

Secondary outcome measures

Change in pain scale post ketorolac administration at different time points

Dose of additional rescue analgesia needed

Need for additional rescue analgesia

+1 more

Trial Design

2Treatment groups

Active Control

Group I: 15mg IV KetorolacActive Control1 Intervention

Patients will be randomized to 15mg IV ketorolac

Group II: 30mg IV KetorolacActive Control1 Intervention

Patients will be randomized to 30mg IV ketorolac

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor

131 Previous Clinical Trials

28,044 Total Patients Enrolled

Biren Bhatt, MDPrincipal InvestigatorHackensack Meridian Health

Frequently Asked Questions

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

Is the inclusion criteria for this research study limited to individuals who are above 30 years old?

"To be eligible for this clinical investigation, individuals must satisfy the age criterion of being at least 18 years old and not exceeding 65 years."

Answered by AI

What is the current number of individuals being recruited for participation in this clinical research study?

"Indeed, the information available on clinicaltrials.gov confirms that this trial is actively seeking participants. The study was initially posted on December 21st, 2023 and was most recently updated on the same date. The trial aims to enroll a total of 200 participants from a single location."

Answered by AI

Are potential participants currently able to apply for enrollment in this trial?

"Indeed, the details on clinicaltrials.gov indicate that this particular trial is currently in search of eligible individuals. The initial posting for this clinical trial took place on December 21st, 2023 and the most recent update was made on the same day. The study aims to recruit a total of 200 participants from a single location."

Answered by AI

Who meets the criteria to participate in this medical study?

"This clinical study aims to include 200 individuals seeking pain relief, aged between 18 and 65 years. Notably, eligible participants should meet the following requirements: Adults visiting an emergency department who are below the age of 65, experiencing flank pain as their primary complaint, reporting a numerical rating scale (NRS) pain score of equal to or greater than 4 out of 10, and having determined treatment with intravenous ketorolac."

Answered by AI

Has the United States Food and Drug Administration given their approval for intravenous administration of ketorolac at a dosage of 15 milligrams?

"Based on our assessment at Power, the safety rating for 15mg IV Ketorolac is a solid 3. This determination is influenced by the fact that this trial falls under Phase 4, indicating that the treatment has already received approval."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients

2023. "Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05776953.