Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Nontraumatic Musculoskeletal Pain
Condition: Musculoskeletal Pain
MeSH terms: Musculoskeletal 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 acute non traumatic
           musculoskeletal pain.

        -  The objective of the study is compare the efficacy of intravenous dexketoprofen with
           paracetamol in the treatment of acute non-traumatic musculoskeletal pain.
    

Detailed description: 
      -  This is the randomized double blinded clinical trial to compare the efficacy of these
           two 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) 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 acute non-traumatic musculoskeletal 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 two groups:

      First Group: 1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol-Myers Squibb_UK)
      intravenous (IV) was given 100 patients, Second Group: dexketoprofen 50 mg ( arveles ampoule
      -Ufsa- Istanbul) intravenous (IV) was given 100 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 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 acute non-traumatic musculoskeletal pain scores.

        -  Patients in both groups received two types of medication in a similar manner, thus
           ensuring double blind.

        -  Acute non-traumatic musculoskeletal pain scores were recorded at 0, 15, 30 and 60 min on
           a VAS of 1 to 10

        -  Rescue medication (Fentanyl 1mcg/kg) was given intravenous to patients if pain VAS
           scores ≥ 5 in sixty minutes after study drug administration.

        -  All other medications required during the study also were recorded.

        -  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
Intervention type(s): Drug; Drug
Intervention description(s): 1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100patients; Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
Other intervention name(s): Perfalgan; ASEKET; DARKIN; DEXALGIN; DESTIYO; DEXCORIL
Intervention MeSH terms: Acetaminophen; Dexketoprofen trometamol
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: paracetamol; dexketoprofen; emergency department; musculoskeletal pain