NCT03428503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

February 5, 2018

Last Update Submit

February 8, 2018

Conditions

Musculoskeletal Pain

Keywords

paracetamoldexketoprofenemergency departmentmusculoskeletal pain

Outcome Measures

Primary Outcomes (1)

  • 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)

    Baseline and 60 minutes

Study Arms (2)

Paracetamol

EXPERIMENTAL

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

Drug: Paracetamol

Dexketoprofen

EXPERIMENTAL

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

Drug: Dexketoprofen

Interventions

ParacetamolDRUG

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

Also known as: Perfalgan
Paracetamol
DexketoprofenDRUG

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

Also known as: ASEKET, DARKIN, DEXALGIN, DESTIYO, DEXCORIL
Dexketoprofen

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Isolated traumatic musculoskeletal pain
  • Patients who agree to work and receive the approval
  • VAS (visual analog scale) score\>5.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, 20070, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 30100336DERIVED

MeSH Terms

Conditions

Musculoskeletal PainEmergencies

Interventions

Acetaminophendexketoprofen trometamol

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Atakan Yilmaz, MD

    Pamukkale University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 9, 2018

Study Start

December 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 9, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)