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Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01318187
First Posted: March 18, 2011
Last Update Posted: April 1, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pamukkale University
  Purpose

STUDY OBJECTIVE: This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol and morphine for the treatment of acute flank pain.

METHODS: The investigators conducted a randomized, double-blind, controlled clinical trial comparing single intravenous doses of paracetamol (1 g) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with acute flank pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg).


Condition Intervention Phase
Urolithiasis Drug: paracetamol Drug: morphine Drug: Paracetamol Drug: Morphine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain : a Randomized, Double Blind, Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Pamukkale University:

Primary Outcome Measures:
  • Reduction in visual analogue scale [ Time Frame: 15 minutes interval ]
    The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered.


Secondary Outcome Measures:
  • Adverse events. [ Time Frame: 30th minutes after ]
    30th minutes after the study drug administered


Enrollment: 73
Study Start Date: January 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Paracetamol Drug: paracetamol
1 gr
Other Name: Perfalgan
Drug: morphine
0.1mg/kg intravenous in 100 ml serum physiologic
Other Name: Morphine CHL 0.01 gr
Drug: Paracetamol
1 gr intravenous
Other Name: Perfalgan
Drug: Paracetamol
intravenous 1 gr
Other Name: Perfalgan
Active Comparator: Morphine Drug: paracetamol
1 gr
Other Name: Perfalgan
Drug: morphine
0.1mg/kg intravenous in 100 ml serum physiologic
Other Name: Morphine CHL 0.01 gr
Drug: Morphine
0.1 mg/kg intravenous

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adults (aged 16 to 55 years old) with acute low back pain were eligible for inclusion in the study

Exclusion Criteria:

  • known allergy or contraindication to morphine, paracetamol, or any opioid analgesic
  • hemodynamic instability; fever (temperature > 38°C [100.4°F])
  • evidence of peritoneal inflammation
  • documented or suspected pregnancy
  • known or suspected aortic dissection or aneurysm
  • use of any analgesic within 6 hours of ED presentation
  • previous study enrollment Patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01318187


Locations
Turkey
Pamukkale University Hospital Emergency Department
Denizli, Turkey, 20020
Pamukkale University
Denizli, Turkey
Sponsors and Collaborators
Pamukkale University
Investigators
Study Director: Mustafa Serinken, Proffesor Pamukkale University
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pamukkale University
ClinicalTrials.gov Identifier: NCT01318187     History of Changes
Other Study ID Numbers: serinken 001
First Submitted: March 17, 2011
First Posted: March 18, 2011
Last Update Posted: April 1, 2011
Last Verified: January 2011

Keywords provided by Pamukkale University:
renal colic
paracetamol
morphine
emergency department

Additional relevant MeSH terms:
Urolithiasis
Flank Pain
Urologic Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Morphine
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antipyretics


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