Clinical trial NCT05776953: Evaluation of the Effects of Ketorolac Dose on Duration of Analgesia in Emergency Department (ED) Renal Colic Patients
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Renal Colic
Flank Pain
Emergencies
Analgesia
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in pain scale post ketorolac administration
timeFrame: At 120 minutes from medication administration
Secondary outcomes:
measure: Change in pain scale post ketorolac administration at different time points
timeFrame: At 90 minutes from medication administration
measure: Change in pain scale post ketorolac administration at different time points
timeFrame: At 150 minutes from medication administration
measure: Change in pain scale post ketorolac administration at different time points
timeFrame: At 180 minutes from medication administration
measure: Need for additional rescue analgesia
timeFrame: At 120 minutes from medication administration
measure: Type of additional rescue analgesia needed
timeFrame: At 120 minutes from medication administration
measure: Dose of additional rescue analgesia needed
timeFrame: At 120 minutes from medication administration
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack Univarsity medical Center
state: New Jersey
Study officials:
affiliation: Hackensack Meridian Health
name: Biren Bhatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.