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IV Paracetamol, Dexketoprofen or Morphine for the Treatment of Low Back Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mustafa Serinken, Pamukkale University
ClinicalTrials.gov Identifier:
NCT01422291
First received: August 22, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

This randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.


Condition Intervention Phase
Low Back Pain
 Drug: paracetamol
Drug: morphine
Drug: Dexketoprofen
Drug: Paracetamole
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: Pamukkale University Medical School,Dept. of Emergency Medicine

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
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: 30 minutes after ] [ Designated as safety issue: Yes ]
    30 minutes after the study drug administered


Enrollment: 120
Study Start Date: January 2011
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: morphine Drug: Paracetamole
1 gr
Other Name: Perfalgan
Experimental: Paracetamole, dexketoprofen
Paracetamole, dexketoprofen
 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: Dexketoprofen
50 mg
Other Name: Arveles
Drug: Morphine
0.1mg/kg intravenous in 100 ml serum physiologic
Other Name: Morphine

Detailed Description:

Study Design and Setting:

This is a single-center, prospective, randomized, double-blind, clinical trial performed in an ED of a tertiary care hospital with annual census of approximately 37.000 visits. The local ethics committee approved the study.

Interventions:

We conducted a randomized, controlled clinical trial comparing single intravenous doses of paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ED) with suspected low back pain. Subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). We compared changes in pain intensity 30 minutes after treatment.

Methods of Measurements:

Subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain' and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe pain) just before the drug administration, 15th minutes and 30th minutes after the study drug administration. The demographic features of study patients and adverse effects, nausea, vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry mouth, were recorded to the study form.

Outcome Measures The primary outcome measure was the pain reduction in VAS and VRS at 15th and 30th minutes. Secondary outcome measures were the need for rescue drug and the presence of any adverse event.

Primary Data Analysis:

The present study was planned as a superiority trial. When the 20 mm difference in VAS is accepted as clinically significant and the standard deviation is accepted as 25 mm, 35 patients are needed with each group with 95% power. All the analysis were implemented according to the intention to treat analysis. The precise of differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% CI).

  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) with acute low back pain were eligible for inclusion in the study- -

Exclusion Criteria:

  • Exclusion criteria included known allergy or contraindication to morphine, paracetamol,dexketoprofen 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, lombar disc hernia
  • 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Mustafa Serinken, Pamukkale University
ClinicalTrials.gov Identifier: NCT01422291     History of Changes
Other Study ID Numbers: serinken 002
Study First Received: August 22, 2011
Last Updated: August 22, 2011
Health Authority: Turkey: Ministry of Health

Keywords provided by Pamukkale University:
Low back pain
paracetamol
dexketoprofen
morphine

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
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 23, 2013