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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03665753

Enrollment

165

Registered

2018-09-11

Start date

2018-11-05

Completion date

2019-11-09

Last updated

2020-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Renal Colic

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).

Interventions

DRUGKetorolac

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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Dose escalation study.

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Adverse Effects	60 Minutes	Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026