Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for 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.

Inclusion criteria

• Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger
• Isolated traumatic musculoskeletal pain
• Patients who agree to work and receive the approval
• VAS (visual analog scale) score>5.

Exclusion criteria

• Patients with severe liver, kidney,pulmonary and cardiac heartfailure
• To be Pregnancy and breast-feeding
• Have received analgesics in the last 6hours
• Patients of childbearing age who are not using a birth control method.
• Patients with neurological deficits
• Patients with sciatica and back pain
• Patients with cardiac chest pain
• Patients with chronic pain
• Patients with pre-existing dexketoprofen and paracetamol-induced gastrointestinal bleeding and perforation
• Patients with reflected pain
• Patients with neoplastic pain
• Patients with an allergy trait (paracetamol and dexketoprofen)
• Illiterates and patients with vision problems