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

NCT ID: NCT03428503

Last Updated: 2018-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-31

Brief 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.

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 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.

Conditions

Musculoskeletal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Paracetamol

1000 mg of paracetamol (perfalgan 10mg/ml solution Bristol-Myers Squibb\_UK) intravenous (IV) was given 100 patients

Group Type: EXPERIMENTAL

Paracetamol

Intervention Type: DRUG

1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb\_UK) intravenous (IV) was given 100patients

Dexketoprofen

Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients

Group Type: EXPERIMENTAL

Dexketoprofen

Intervention Type: DRUG

Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients

Interventions

Paracetamol

1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb\_UK) intravenous (IV) was given 100patients

Intervention Type: DRUG

Dexketoprofen

Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients

Intervention Type: DRUG

Other Intervention Names

Perfalgan; ASEKET; DARKIN; DEXALGIN; DESTIYO; DEXCORIL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pamukkale University

OTHER

Sponsor Role: lead

Responsible Party

Ibrahim Turkcuer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atakan Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

Pamukkale University

Denizli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Yilmaz A, Sabirli R, Ozen M, Turkcuer I, Erdur B, Arikan C, Demirozogul E, Sarohan A, Seyit M, Ok N. Intravenous paracetamol versus dexketoprofen in acute musculoskeletal trauma in the emergency department: A randomised clinical trial. Am J Emerg Med. 2019 May;37(5):902-908. doi: 10.1016/j.ajem.2018.08.023. Epub 2018 Aug 8.

Reference Type: DERIVED

PMID: 30100336 (View on PubMed)

Other Identifiers

2015HZL031

Identifier Type: -

Identifier Source: org_study_id