Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain
Condition: Low Back Pain, Mechanical
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      -  Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by
           emergency physicians in Turkey for the treatment of patients with Non-Traumatic Acute
           Low Back Pain

        -  The objective of the study is compare the efficacy of intravenous
           dexketoprofen,ibuprofen with paracetamol in the treatment of Non-Traumatic Acute Low
           Back Pain
    

Detailed description: 
      -  This is the randomized double blinded clinical trial to compare the efficacy of these
           three drugs in this clinical setting.

        -  A randomized clinical trial was conducted in the Emergency Department (ED) of Pamukkale
           University Medical Faculty Hospital

        -  Study personnel (emergency physicians and nurses) were trained before the study.

        -  When intravenous drugs (Paracetamol, Dexketoprofen and ibuprofen) was being recommended,
           an eligibility checklist was completed by the attending physician.

        -  If there were no exclusion criteria, written informed consent was obtained and baseline
           information, including initial Non-Traumatic Acute Low Back Pain severity ratings with
           visual analog scale (VAS) were recorded.

        -  The need for identification and enrollment of participants by staff with conflicting
           work pressures resulted in recruitment of a convenience sample of patients.

        -  All patients eligible for the study were randomized to one of three groups:

      First Group: 1000 mg of paracetamol (parol 1000mg vial-atabay chemistry-İstanbul )
      intravenous (IV) was given 71 patients, Second Group: dexketoprofen 50 mg ( arveles 50 mg
      ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg
      İbuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which
      determined to be applied as a group. Drug packs prepared in 150 ml serum physiology were
      numbered by an independent nurse, who not involved in the study.

        -  Drugs were prepared according to the computer-generated random number sequence to assign
           treatment allocations

        -  The allocation list was kept by the emergency nurse. Patients received the
           paracetamol,dexketoprofen,ibuprofen medication schemes according to their random
           allocations.

        -  After enrollment and recording of baseline information, the next numbered study drug
           pack was obtained, and administered intravenously.

        -  Randomization was achieved by using computer software to generate random numbers. During
           the intervention, participants were monitored by an oxygen saturation (SpO2) monitor, an
           automatic sphygmomanometer (blood pressure), and a rhythm monitor (heart rate and
           rhythms)

        -  One researcher blinded to patient allocation observed the whole procedure and recorded
           the Non-Traumatic Acute Low Back Pain scores.

        -  Patients in three groups received three types of medication in a similar manner, thus
           ensuring double blind.

      Non-Traumatic Acute Low Back Pain scores were recorded at 0, 15, 30 and 60 min on a VAS of 1
      to 100

      • During the study, pulse rate, systolic blood pressure, diastolic blood pressure,
      respiration rate and oxygen saturation (SpO2) were recorded at baseline (0 min), 15, 30, and
      60 min.
    

Intervention name(s): Paracetamol; Dexketoprofen; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,; dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,; 400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.
Other intervention name(s): Perfalgan; ASEKET; DARKIN; DEXALGIN; DESTIYO; DEXCORIL; İntrafen
Intervention MeSH terms: Acetaminophen; Ibuprofen; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: paracetamol; dexketoprofen; ibuprofen; emergency department; low back pain