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Completed

NCT Number: NCT01546701

Buprenorphine in Acute Renal Colic Pain Management

The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

TUMS

Tehran, Tehran Province, 1417613151, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.

Exclusion criteria

  • previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
  • febrile patients (T > 38°C);
  • hemodynamically unstable patients ( Systolic Blood Pressure < 90 mmHg);
  • pregnant patients;
  • patients with abdominal tenderness as a sign of peritoneal inflammation;
  • any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection;
  • patients with a history of drug addiction or known allergy to opioids;
  • patients who had used analgesics 6 hours before arriving.

Treatment and study plan

buprenorphine

Drug

2 mg sublingual tablet

Morphine

Drug

0.1 mg/kg IV morphine

Primary outcomes

  1. change in pain score

    Time frame: 20 and 40 minutes

    change in pain severity based on Numerical Rating Score

Secondary outcomes

  1. treatment side effects

    Time frame: 40 minutes

    experiencing any side effects by the patients as a result of treatment protocols.

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Mar 7, 2012
Registry last updated
Dec 10, 2012

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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