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

Sponsor

Tehran University of Medical Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT03665753

Collaborator

(none)

165

Enrollment

Location

Arms

12.1

Actual Duration (Months)

13.6

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Pain Renal Colic	Drug: Ketorolac	Early Phase 1

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

165 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Dose escalation study.Dose escalation study.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparison of Intravenous Ketorolac 10, 20, and 30mg for Treating Renal Colic Pain in the Emergency Department: A Randomized Controlled Trial

Actual Study Start Date :

Nov 5, 2018

Actual Primary Completion Date :

Sep 9, 2019

Actual Study Completion Date :

Nov 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ketorolac 10mg Subjects will be administered 10 mg of Ketorolac.	Drug: Ketorolac Subject will receive 10, 20, and 30mg of Ketorolac.
Experimental: Ketorolac 20mg Subjects will be administered 20 mg of Ketorolac	Drug: Ketorolac Subject will receive 10, 20, and 30mg of Ketorolac.
Experimental: Ketorolac 30mg As a part of standard care, subjects will be administered 30 mg of Ketorolac.	Drug: Ketorolac Subject will receive 10, 20, and 30mg of Ketorolac.

Arm

Intervention/Treatment

Experimental: Ketorolac 10mg

Subjects will be administered 10 mg of Ketorolac.

Drug: Ketorolac

Subject will receive 10, 20, and 30mg of Ketorolac.

Experimental: Ketorolac 20mg

Subjects will be administered 20 mg of Ketorolac

Drug: Ketorolac

Subject will receive 10, 20, and 30mg of Ketorolac.

Experimental: Ketorolac 30mg

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

Drug: Ketorolac

Subject will receive 10, 20, and 30mg of Ketorolac.

Outcome Measures

Primary Outcome Measures

Pain assessed with visual analogue scale (VAS) [30 Minutes]
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) [15 Minutes]
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) [45 Minutes]
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) [60 Minutes]
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 [60 Minutes]
Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	IKCH	Tehran		Iran, Islamic Republic of

Sponsors and Collaborators

Tehran University of Medical Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hadi Mirfazaelian, Assistant Professor of Emergency Medicine, Tehran University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT03665753

Other Study ID Numbers:

9521307004

First Posted:

Sep 11, 2018

Last Update Posted:

Jul 7, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colic

Renal Colic

Ketorolac

Study Results

No Results Posted as of Jul 7, 2020