Actively Recruiting

Phase 4
Age: 18Years - 65Years
All Genders
ID05776953

Evaluation of the Effects of Ketorolac 15mg IV Versus 30mg IV on Duration of Analgesia in Patients Who Present to the Emergency Department With Renal Colic

Led by Hackensack Meridian Health · Updated on 2026-05-22

86

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how different doses of ketorolac affect pain relief duration in adults with suspected renal colic who visit the emergency department. This study focuses on comparing 15 mg versus 30 mg intravenous ketorolac to determine which dose provides longer-lasting pain control, especially noting that previous studies have not fully assessed ketorolac's peak analgesic effect at 120 minutes. The study is a prospective, randomized, triple-blind trial aiming to better understand optimal dosing for this common cause of emergency pain. Participants will be randomly assigned to receive either 15 mg or 30 mg of intravenous ketorolac. The study will monitor pain reduction at 120 minutes after dosing, with additional measurements at 90, 150, and 180 minutes. Researchers will also track if participants need extra pain medication and details about any additional analgesics used. The goal is to identify the dose that maintains effective pain relief while minimizing side effects. During the study, participants will have their pain evaluated at multiple time points using a pain scale. Researchers will collect information on the need for rescue pain medication and type and dose of such medication. The study includes adults aged 18 to 65 who present with moderate to severe pain associated with suspected renal colic. Participation involves receiving the study drug and undergoing pain assessments over several hours in the emergency department setting.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults under 65 years old presenting to the Emergency Department
  • Presenting with one or more complaints linked to suspected renal colic such as flank, back, abdominal, lower quadrant, or pelvic pain
  • Pain score of 4 or greater on a 0-10 numeric rating scale
  • Treatment plan includes intravenous ketorolac administration
Not Eligible

You will not qualify if you...

  • Allergy to ketorolac
  • Pregnancy
  • Received analgesic medications within 4 hours before ketorolac administration in the Emergency Department
  • Known or reported renal insufficiency
  • Body weight less than 50 kg
  • Age over 65 years
  • Inability to read or write in Spanish or English

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) at the Emergency Department for eligibility assessment

Treatment

Duration - Single administration with observation up to 180 minutes

Participants receive either 15mg or 30mg intravenous ketorolac for acute renal colic pain management in the Emergency Department.

1 treatment visit with observation visits at 90, 120, 150, and 180 minutes after medication administration

Trial Site Locations

Total: 1 location

1

Hackensack Univarsity medical Center

Hackensack, New Jersey, United States, 07601

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Research Team

B

Biren Bhatt, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial.

Sergey Motov, Matthew Yasavolian, Antonios Likourezos...

https://pubmed.ncbi.nlm.nih.gov/27993418

Comparison of intravenous ketorolac at three doses for treating renal colic in the emergency department: A noninferiority randomized controlled trial.

Lily Eidinejad, Maryam Bahreini, Ayat Ahmadi...

https://pubmed.ncbi.nlm.nih.gov/33370510