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NCT Number: NCT05776953

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

This is a prospective interventional study examining the effect of ketorolac at doses of 15mg versus 30 mg for duration of analgesia in emergency department patients with suspected renal colic.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hackensack Univarsity medical Center

Hackensack, New Jersey, 07601, United States

Location status: Recruiting

Location contact

Sujatha Iyengar, PhD

SUB_INVESTIGATOR

About this study

Pain is a common emergency department complaint. With various types of analgesics available, the optimal drug is one that provides adequate pain management with minimal side effects. The goal is to effectively treat the patient while maintaining adequate flow in the emergency department. In cases of moderate to severe pain in emergency departments, opioids have been the gold standard.1 Opiates, such as morphine, are associated with side effects that can be distressing to the patient, as well as, costly to the department. Prescribing opiates includes a reluctance in administering sufficient opioid dosing due to fear of tolerance and dependency.2

It has been demonstrated in other studies that the standard dosing of ketorolac is higher than needed to achieve analgesia but have failed to show to what duration of time analgesia is maintained between the dosages. The study will compare the analgesic efficacy of two doses of intravenous ketorolac (15mg and 30mg) for acute flank pain in the Emergency Department (ED), such as renal colic, and how efficacious the pain was controlled at 120 minutes or upon discharge. Motov et al evaluated the effectiveness of ketorolac in moderate to severe pain with a primary endpoint of 30 minutes, however the peak onset of ketorolac is 120 to 180 minutes.

Our study may further investigate the ceiling dose of intravenous ketorolac. The primary outcome of both Motov et al and Eidinejad et al was pain reduction 30 minutes after ketorolac administration.3,4 These studies differed in the aspect that Eidinejad et al study examined pain reduction up to 60 minutes, while Motov et al observed up to 120 minutes after administration of ketorolac.3,4 Ketorolac has a peak time of onset at 2 to 4 hours. These studies are not observing ketorolac at its optimal analgesic potency. Therefore, a study is proposed to compare 15 mg vs 30 mg intravenous ketorolac with the primary outcome being pain reduction in renal colic at 120 minutes. Nephrolithiasis and ureterolithiasis are the most common diagnoses in the emergency department for which ketorolac is prescribed.5 This study may further evaluate optimal intravenous ketorolac dosing in pathology it is known to be the most advantageous.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients will be included if they present to the Emergency Department with (all of the following):

  • Adult emergency department patients < 65 years old
  • One or more of the following common ED chief complaints associated with the suspected diagnosis of renal colic. These chief complaints include but are not limited to: flank pain, back pain, abdominal pain, left and/or right lower quadrant pain, and/or pelvic pain
  • Pain score of 4 or greater on the 0-10 NRS
  • Determination of treatment with IV ketorolac

Exclusion criteria

Patients will be excluded if any of the following apply:

  • Allergy to ketorolac
  • Pregnant patients
  • Previously received analgesic medications within 4 hours prior to administration of ketorolac in our ED
  • Known or stated history of renal insufficiency
  • Body weight < 50 kg
  • Age greater than 65 years
  • Patients that do no read/write Spanish or English

Treatment and study plan

Ketorolac

Drug

IV Ketorolac for pain

Primary outcomes

  1. Change in pain scale post ketorolac administration

    Time frame: At 120 minutes (+/-10 minutes) from medication administration

    This study may prospectively compare the mean Numerical Rating Scale (NRS) pain score reduction of 15 mg versus 30 mg of intravenous (IV) ketorolac at 120 minutes after administration to treat renal colic in the emergency department. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".

Secondary outcomes

  1. Change in pain scale post ketorolac administration at different time points

    Time frame: At 90 minutes (+/-10 minutes) from medication administration

    This study may also determine the mean NRS pain score reduction at different time points (90 minutes, 150 minutes, and 180 minutes) after IV ketorolac administration. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".

  2. Change in pain scale post ketorolac administration at different time points

    Time frame: At 150 minutes (+/-10 minutes) from medication administration

    This study may also determine the mean NRS pain score reduction at different time points (90 minutes, 150 minutes, and 180 minutes) after IV ketorolac administration. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".

  3. Change in pain scale post ketorolac administration at different time points

    Time frame: At 180 minutes (+/-10 minutes) from medication administration

    This study may also determine the mean NRS pain score reduction at different time points (90 minutes, 150 minutes, and 180 minutes) after IV ketorolac administration. The scale ranges from 0 to 10 with 0 being "no pain" and 10 being "very much pain".

  4. Need for additional rescue analgesia

    Time frame: At 120 minutes from medication administration

    Study may also examine the number of patients requesting rescue analgesia within two hours of ketorolac administration (yes vs. no)

  5. Type of additional rescue analgesia needed

    Time frame: At 120 minutes from medication administration

    For the patients who need additional pain medication, we will collect the type of medication provided.

  6. Dose of additional rescue analgesia needed

    Time frame: At 120 minutes from medication administration

    For the patients who need additional pain medication, we will collect the dose of medication provided.

Study contacts

Contact information is provided by the study sponsor or research team.

Biren Bhatt, MD

CONTACT

[email protected]

551-996-2000 ext. 5485

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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