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

NCT05776953 | Recruiting Phase 4 FDA Drug

• 1 other identifier: Pro2022-0546
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Colic; Flank Pain; Emergencies; Analgesia

Outcome Measures

Primary Outcomes (1)

• Change in pain scale post ketorolac 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".

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

Secondary Outcomes (6)

• Change in pain scale post ketorolac administration at different time points

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

• Change in pain scale post ketorolac administration at different time points

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

• Change in pain scale post ketorolac administration at different time points

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

• Need for additional rescue analgesia

  At 120 minutes from medication administration

• Type of additional rescue analgesia needed

  At 120 minutes from medication administration

Study Arms (2)

15mg IV Ketorolac

ACTIVE COMPARATOR

Patients will be randomized to 15mg IV ketorolac

Drug: Ketorolac

30mg IV Ketorolac

ACTIVE COMPARATOR

Patients will be randomized to 30mg IV ketorolac

Drug: Ketorolac

Interventions

Ketorolac DRUG

IV Ketorolac for pain

15mg IV Ketorolac; 30mg IV Ketorolac

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Univarsity medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Related Publications (5)

• Jelinek GA. Ketorolac versus morphine for severe pain. Ketorolac is more effective, cheaper, and has fewer side effects. BMJ. 2000 Nov 18;321(7271):1236-7. doi: 10.1136/bmj.321.7271.1236. No abstract available.

  PMID: 11082068 BACKGROUND

• Catapano MS. The analgesic efficacy of ketorolac for acute pain. J Emerg Med. 1996 Jan-Feb;14(1):67-75. doi: 10.1016/0736-4679(95)02052-7.

  PMID: 8655940 BACKGROUND

• Motov S, Yasavolian M, Likourezos A, Pushkar I, Hossain R, Drapkin J, Cohen V, Filk N, Smith A, Huang F, Rockoff B, Homel P, Fromm C. Comparison of Intravenous Ketorolac at Three Single-Dose Regimens for Treating Acute Pain in the Emergency Department: A Randomized Controlled Trial. Ann Emerg Med. 2017 Aug;70(2):177-184. doi: 10.1016/j.annemergmed.2016.10.014. Epub 2016 Dec 16.

  PMID: 27993418 BACKGROUND

• Eidinejad L, Bahreini M, Ahmadi A, Yazdchi M, Thiruganasambandamoorthy V, Mirfazaelian H. Comparison of intravenous ketorolac at three doses for treating renal colic in the emergency department: A noninferiority randomized controlled trial. Acad Emerg Med. 2021 Jul;28(7):768-775. doi: 10.1111/acem.14202. Epub 2021 Feb 17.

  PMID: 33370510 BACKGROUND

• Soleyman-Zomalan E, Motov S, Likourezos A, Cohen V, Pushkar I, Fromm C. Patterns of Ketorolac dosing by emergency physicians. World J Emerg Med. 2017;8(1):43-46. doi: 10.5847/wjem.j.1920-8642.2017.01.008.

  PMID: 28123620 BACKGROUND

MeSH Terms

Conditions

Renal Colic; Flank Pain; Emergencies; Agnosia

Interventions

Ketorolac

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Biren Bhatt, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Biren Bhatt, MD

CONTACT

551-996-2000; biren.bhatt@hmhn.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The patient, treating provider, and the investigator will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 20, 2023
• Study Start: December 21, 2023
• Primary Completion: March 28, 2026
• Study Completion: March 28, 2026
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)