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

NCT ID: NCT01422291

Last Updated: 2011-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-07-31

Brief 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.

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).

Conditions

Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

morphine

Group Type: ACTIVE_COMPARATOR

Paracetamole

Intervention Type: DRUG

1 gr

Paracetamole, dexketoprofen

Paracetamole, dexketoprofen

Group Type: EXPERIMENTAL

paracetamol

Intervention Type: DRUG

1 gr

morphine

Intervention Type: DRUG

0.1mg/kg intravenous in 100 ml serum physiologic

Dexketoprofen

Intervention Type: DRUG

50 mg

Interventions

paracetamol

1 gr

Intervention Type: DRUG

morphine

0.1mg/kg intravenous in 100 ml serum physiologic

Intervention Type: DRUG

Dexketoprofen

50 mg

Intervention Type: DRUG

Paracetamole

1 gr

Intervention Type: DRUG

Other Intervention Names

Perfalgan; Morphine CHL 0.01 gr; Arveles; Perfalgan

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Mustafa Serinken

Pamukkale University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

serinken 002

Identifier Type: -

Identifier Source: org_study_id