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

Low Back Pain Clinical Trial

Official title:

Pamukkale University Medical School,Dept. of Emergency Medicine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01422291
• Other study ID #: serinken 002
• Status: Completed
• Phase: Phase 4
• First received: August 22, 2011
• Last updated: August 22, 2011
• Start date: January 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Pamukkale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• paracetamol
1 gr
• morphine
0.1mg/kg intravenous in 100 ml serum physiologic
• Dexketoprofen
50 mg
• Paracetamole
1 gr

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pamukkale University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in visual analogue scale	The pain of the study subjects was measured after 15th and 30th minutes later after the study drug administered	15 minutes interval	No
Secondary	Adverse events.	30 minutes after the study drug administered	30 minutes after	Yes