Comparison of Efficacy of Intravenous Paracetamol and Dexketoprofen for Acute Traumatic Musculoskeletal Pain in the Emergency Department: A Double-Blinded, Randomized, Controlled Trial
| Registry | NCT03428503 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, factorial, masking: triple, treatment |
| Enrollment | 200 (Actual) |
| Sponsor | Pamukkale University (Other) |
| Conditions | Musculoskeletal Pain |
| Interventions | Paracetamol, Dexketoprofen (Drug) |
| Dates | start 2015-12-01, primary completion 2016-12-01, completion 2016-12-01, first posted 2018-02-09, last updated 2018-02-09 |
| Locations | 1 site in Turkey (Türkiye) |
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All trials for Musculoskeletal Pain All trials of Paracetamol All trials of Dexketoprofen
* 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Paracetamol | Experimental | Drug: Paracetamol | 1000 mg of paracetamol (perfalgan 10mg/ml solution Bristol-Myers Squibb_UK) intravenous (IV) was given 100 patients |
| Dexketoprofen | Experimental | Drug: Dexketoprofen | Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients |
Sex: All, ages: 18 Years to 65 Years
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
| Facility | City | Country | Status |
|---|---|---|---|
| Pamukkale University | Denizli | Turkey (Türkiye) |