* Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with acute traumatic musculoskeletal pain. * The objective of the study is compare the efficacy of intravenous dexketoprofen with paracetamol in the treatment of acute traumatic musculoskeletal pain.
* 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 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 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
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
Pamukkale University
Denizli, Turkey (Türkiye)
Decrement of the pain on VAS
Comparison of the reduction of traumatic musculoskeletal pain VAS (visual analog scale) score between the two groups. - (First group Paracetamol and Second Dexketoprofen)
Time frame: Baseline and 60 minutes
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