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

Analgesia Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05776953
• Other study ID #: Pro2022-0546
• Status: Recruiting
• Phase: Phase 4
• Start date: December 21, 2023
• Est. completion date: December 20, 2024

Study information

• Verified date: May 2024
• Source: Hackensack Meridian Health
• Contact: Biren Bhatt, MD
• Phone: 551-996-2000
• Email: biren.bhatt[@]hmhn.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

• Complaint of flank 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 (eGFR < 50 ml/min/1.73 m2)

• Body weight < 50 kg

• Age greater than 65 years

• Patients that do no read/write Spanish or English

Related Conditions & MeSH terms

• Analgesia
• Colic
• Emergencies
• Flank Pain
• Renal Colic

Intervention

Drug:
• Ketorolac
IV Ketorolac for pain

Locations

Country	Name	City	State
United States	Hackensack Univarsity medical Center	Hackensack	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Hackensack Meridian Health

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 from medication administration
Secondary	Change in pain scale post ketorolac administration at different time points	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".	At 90 minutes from medication administration
Secondary	Change in pain scale post ketorolac administration at different time points	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".	At 150 minutes from medication administration
Secondary	Change in pain scale post ketorolac administration at different time points	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".	At 180 minutes from medication administration
Secondary	Need for additional rescue analgesia	Study may also examine the number of patients requesting rescue analgesia within two hours of ketorolac administration (yes vs. no)	At 120 minutes from medication administration
Secondary	Type of additional rescue analgesia needed	For the patients who need additional pain medication, we will collect the type of medication provided.	At 120 minutes from medication administration
Secondary	Dose of additional rescue analgesia needed	For the patients who need additional pain medication, we will collect the dose of medication provided.	At 120 minutes from medication administration