NCT06060236

Brief Summary

The aim of this study was to compare the efficacy of ibuprofen and dexketoprofen, two common analgesic drugs used in pain control in patients with long bone fractures.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4 pain

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

October 2, 2023

Status Verified

September 1, 2023

Enrollment Period

1 year

First QC Date

September 23, 2023

Last Update Submit

September 28, 2023

Conditions

PainBone Fracture

Keywords

Long bone fractureibuprofendexketoprofenpain

Outcome Measures

Primary Outcomes (1)

  • Visual analog scale

    The pain is determined using a 100 mm scale. Patients are instructed to mark the level of pain they experience, with 0 mm indicating no pain and 100 mm indicating the presence of maximum pain.

    120 minute

Study Arms (2)

ibuprofen

EXPERIMENTAL

ibuprofen intravenous 800 mg

Drug: Ibuprofen 800 mg

dexketoprofen

EXPERIMENTAL

dexketoprofen intravenous 50 mg

Drug: Dexketoprofen

Interventions

Ibuprofen 800 mgDRUG

Ibuprofen 800 Mg İv

ibuprofen
DexketoprofenDRUG

Dexketoprofen 50 Mg İV

dexketoprofen

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18 years
  • Patients under 80 years of age
  • Patients who agreed to participate in the study
  • One of the tibia, femur and humerus bones is broken
  • Patients with a VAS score of 50 and above
  • Patients with no other injuries requiring emergency surgery
  • Previously known adverse reactions to the active ingredient of the drugs to be used patients with no history
  • Conscious patients
  • Oriented cooperative patients

You may not qualify if:

  • Patients under the age of 18 and over the age of 80
  • Patients who did not agree to participate in the study
  • Patients with vital signs outside the normal limits
  • Patients with a history of adverse reactions to known NSAIDs
  • Those who cannot determine the severity of pain on the VAS
  • Patients with a VAS Score of 50 mm or less
  • Those with other orthopedic injuries pregnant women
  • Those with advanced systemic disease
  • Those with malignancy
  • Those with chronic liver and kidney disease
  • Those who use neuro-psychiatric drugs with sedative and analgesic effects
  • Those with a history of psychological and neurological diseases
  • Patients using analgesics 8 hours before the examination

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, 06170, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Poonai N, Bhullar G, Lin K, Papini A, Mainprize D, Howard J, Teefy J, Bale M, Langford C, Lim R, Stitt L, Rieder MJ, Ali S. Oral administration of morphine versus ibuprofen to manage postfracture pain in children: a randomized trial. CMAJ. 2014 Dec 9;186(18):1358-63. doi: 10.1503/cmaj.140907. Epub 2014 Oct 27.

    PMID: 25349008RESULT

  • Friday JH, Kanegaye JT, McCaslin I, Zheng A, Harley JR. Ibuprofen provides analgesia equivalent to acetaminophen-codeine in the treatment of acute pain in children with extremity injuries: a randomized clinical trial. Acad Emerg Med. 2009 Aug;16(8):711-6. doi: 10.1111/j.1553-2712.2009.00471.x. Epub 2009 Jul 14.

    PMID: 19624576RESULT

MeSH Terms

Conditions

PainFractures, Bone

Interventions

Ibuprofendexketoprofen trometamol

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Safa Dönmez, MD

    Ankara City Hospital Bilkent

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Safa Dönmez, MD

CONTACT

+905537515545drsafa0131@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Emergency Medicine, M.D. Specialist

Study Record Dates

First Submitted

September 23, 2023

First Posted

September 29, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

October 2, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)