Text Size

Intravenous Paracetamol or Morphine for the Treatment of Acute Flank Pain

This study has been completed.
Sponsor:
Information provided by:
Pamukkale University
ClinicalTrials.gov Identifier:
NCT01318187
First received: March 17, 2011
Last updated: March 31, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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:

U.S. FDA Resources

Further study details as provided by Pamukkale University:

Primary Outcome Measures:
  • Reduction in visual analogue scale [ Time Frame: 15 minutes interval ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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
Other Name: Morphine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 55 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Additional 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
Study First Received: March 17, 2011
Last Updated: March 31, 2011
Health Authority: Turkey: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 22, 2013