Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain

Musculoskeletal Pain Clinical Trial

Official title: Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial

Status Completed

Clinical Trial Summary

• 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.

Clinical Trial 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 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. ;

Related Conditions & MeSH terms

• Musculoskeletal Pain

• NCT number: NCT03428503
• Study type: Interventional
• Source: Pamukkale University
• Status: Completed
• Phase: Phase 4
• Start date: December 2015
• Completion date: December 2016