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

Primary Purpose

Renal Colic, Flank Pain, Emergencies

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
Hackensack Meridian Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Colic

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    15mg IV Ketorolac

    30mg IV Ketorolac

    Arm Description

    Patients will be randomized to 15mg IV ketorolac

    Patients will be randomized to 30mg IV ketorolac

    Outcomes

    Primary Outcome Measures

    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".

    Secondary Outcome Measures

    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".
    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".
    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".
    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)
    Type of additional rescue analgesia needed
    For the patients who need additional pain medication, we will collect the type of medication provided.
    Dose of additional rescue analgesia needed
    For the patients who need additional pain medication, we will collect the dose of medication provided.

    Full Information

    First Posted
    February 27, 2023
    Last Updated
    August 18, 2023
    Sponsor
    Hackensack Meridian Health
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05776953
    Brief Title
    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

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    October 15, 2024 (Anticipated)
    Study Completion Date
    October 15, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hackensack Meridian Health

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Renal Colic, Flank Pain, Emergencies, Analgesia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    The patient, treating provider, and the investigator will be blinded.
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    15mg IV Ketorolac
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomized to 15mg IV ketorolac
    Arm Title
    30mg IV Ketorolac
    Arm Type
    Active Comparator
    Arm Description
    Patients will be randomized to 30mg IV ketorolac
    Intervention Type
    Drug
    Intervention Name(s)
    Ketorolac
    Intervention Description
    IV Ketorolac for pain
    Primary Outcome Measure Information:
    Title
    Change in pain scale post ketorolac administration
    Description
    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".
    Time Frame
    At 120 minutes from medication administration
    Secondary Outcome Measure Information:
    Title
    Change in pain scale post ketorolac administration at different time points
    Description
    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".
    Time Frame
    At 90 minutes from medication administration
    Title
    Change in pain scale post ketorolac administration at different time points
    Description
    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".
    Time Frame
    At 150 minutes from medication administration
    Title
    Change in pain scale post ketorolac administration at different time points
    Description
    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".
    Time Frame
    At 180 minutes from medication administration
    Title
    Need for additional rescue analgesia
    Description
    Study may also examine the number of patients requesting rescue analgesia within two hours of ketorolac administration (yes vs. no)
    Time Frame
    At 120 minutes from medication administration
    Title
    Type of additional rescue analgesia needed
    Description
    For the patients who need additional pain medication, we will collect the type of medication provided.
    Time Frame
    At 120 minutes from medication administration
    Title
    Dose of additional rescue analgesia needed
    Description
    For the patients who need additional pain medication, we will collect the dose of medication provided.
    Time Frame
    At 120 minutes from medication administration

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Biren Bhatt, MD
    Phone
    551-996-2000
    Ext
    5485
    Email
    biren.bhatt@hmhn.org
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Biren Bhatt, MD
    Organizational Affiliation
    Hackensack Meridian Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    11082068
    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.
    Results Reference
    background
    PubMed Identifier
    8655940
    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.
    Results Reference
    background
    PubMed Identifier
    27993418
    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.
    Results Reference
    background
    PubMed Identifier
    33370510
    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.
    Results Reference
    background
    PubMed Identifier
    28123620
    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.
    Results Reference
    background

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

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