Efficacy Study of Different Analgesic Options in Kidney Stone Pain Management

NCT02187614 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1645

Last updated 2015-03-18

No results posted yet for this study

Summary

Abdominal pain is one of the most common presentations to an emergency department (ED). Among patients presenting with abdominal pain, a common diagnosis in the Middle East is renal colic (urolithiasis or Kidney stones). As the patients with renal colic writhe around in agonizing pain, the first priority in an ED from a patient's perspective is fast and safe analgesia and to be pain free as early as possible. There are variations in physician preference to choose initial analgesic drug for managing such pain. Commonly used drugs are:

* Opioids such as Morphine or Fentanyl
* Non steroidal drugs such as Diclofenac, Ketorolac or Brufen
* and Paracetamol intravenous injection.

A robust evidence in comparison of diclofenac versus morphine and paracetamol is lacking. This study is design to obtain data on efficacy of these three drugs within 30 minutes in a non inferiority trail.

Conditions

  • Renal Colic
  • Urinary Calculi

Interventions

DRUG

Diclofenac

DRUG

Morphine

DRUG

Placebos

Sponsors & Collaborators

  • Hamad Medical Corporation

    lead INDUSTRY

Principal Investigators

  • Dr.Sameer A. Pathan, MBBS, MCEM · Hamad Medical Corporation

  • Prof. Peter A Cameron, MD,FACEM · Hamad Medical Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-02-28
Completion
2015-03-31

Countries

  • Qatar

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02187614 on ClinicalTrials.gov