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OpenTrials
Completed

NCT Number: NCT03665753

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

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

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Renal Colic Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

IKCH

Tehran, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ketorolac

Drug

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

Primary outcomes

  1. Pain assessed with visual analogue scale (VAS)

    Time frame: 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 outcomes

  1. Pain assessed with visual analogue scale (VAS)

    Time frame: 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.

  2. Pain assessed with visual analogue scale (VAS)

    Time frame: 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.

  3. Pain assessed with visual analogue scale (VAS)

    Time frame: 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.

  4. Adverse Effects

    Time frame: 60 Minutes

    Dizziness (Adverse Effect), Nausea (Adverse Effect), Vomiting (Adverse Effect), headache (Adverse Effect)

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 11, 2018
Registry last updated
Jul 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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