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Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED

Primary Purpose

Pain, Renal Colic

Status
Completed
Phase
Early Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ketorolac
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt

Exclusion Criteria:

  • Age >65
  • Active Peptic Ulcer disease
  • Acute Gastrointestinal Hemorrhage
  • Known History of Renal or Hepatic insufficiency
  • History of allergies to NSAIDs

Sites / Locations

  • IKCH

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Ketorolac 10mg

Ketorolac 20mg

Ketorolac 30mg

Arm Description

Subjects will be administered 10 mg of Ketorolac.

Subjects will be administered 20 mg of Ketorolac

As a part of standard care, subjects will be administered 30 mg of Ketorolac.

Outcomes

Primary Outcome Measures

Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.

Secondary Outcome Measures

Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Pain assessed with visual analogue scale (VAS)
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Adverse Effects
Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)

Full Information

First Posted
September 5, 2018
Last Updated
July 4, 2020
Sponsor
Tehran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03665753
Brief Title
Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED
Official Title
Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 5, 2018 (Actual)
Primary Completion Date
September 9, 2019 (Actual)
Study Completion Date
November 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Hypothesis: Intravenous administration of Ketorolac 10 mg and 20 mg is as effective as 30 mg in treating renal colic pain in patients presenting to the emergency department
Detailed Description
Ketorolac is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED). Because of the Ketorolac significant analgesic potency, it is usually used for moderate-to-severe pain. However, ketorolac has several side effects, of which gastrointestinal hemorrhage is most concerning. "Analgesic ceiling" is defined as the dose beyond which no additional analgesia can be achieved and on the other hand, more side effects might be encountered. Several studies suggested 10 mg as analgesic ceiling. Despite this, many recommendations are still advocating several folds higher doses (e.g. 30, 60 mg).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Dose escalation study.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac 10mg
Arm Type
Experimental
Arm Description
Subjects will be administered 10 mg of Ketorolac.
Arm Title
Ketorolac 20mg
Arm Type
Experimental
Arm Description
Subjects will be administered 20 mg of Ketorolac
Arm Title
Ketorolac 30mg
Arm Type
Experimental
Arm Description
As a part of standard care, subjects will be administered 30 mg of Ketorolac.
Intervention Type
Drug
Intervention Name(s)
Ketorolac
Intervention Description
Subject will receive 10, 20, and 30mg of Ketorolac.
Primary Outcome Measure Information:
Title
Pain assessed with visual analogue scale (VAS)
Description
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time Frame
30 Minutes
Secondary Outcome Measure Information:
Title
Pain assessed with visual analogue scale (VAS)
Description
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time Frame
15 Minutes
Title
Pain assessed with visual analogue scale (VAS)
Description
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time Frame
45 Minutes
Title
Pain assessed with visual analogue scale (VAS)
Description
The visual analogue scale (VAS) will be used for the study. The VAS ranges from 0 (no pain) to 100 (very severe pain). The higher the pain scores the higher the pain severity.
Time Frame
60 Minutes
Title
Adverse Effects
Description
Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)
Time Frame
60 Minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Severe flank and abdominal pain which pertains to renal colic according to emergency physician's gestalt Exclusion Criteria: Age >65 Active Peptic Ulcer disease Acute Gastrointestinal Hemorrhage Known History of Renal or Hepatic insufficiency History of allergies to NSAIDs
Facility Information:
Facility Name
IKCH
City
Tehran
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
derived

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Comparison of IV 10, 20, and 30mg for Renal Colic Pain in the ED

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