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"Management of Low Back Pain in the Emergency Department With Different Analgesic Dosages"

NCT06064175 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-10-03

No results posted yet for this study

Summary

The Management of Low Back Pain in the Emergency Department Worldwide, low back pain is one of the most prevalent musculoskeletal disorders, and it constitutes one of the primary complaints in emergency departments. A review of the literature reveals studies comparing ibuprofen to various agents (such as paracetamol, nimesulide, acetaminophen), and these studies suggest the use of ibuprofen due to its similar or superior efficacy and its safety profile. However, there is a lack of randomized controlled double-blind comparisons between the commonly recommended single doses of ibuprofen, which are 400 mg and 800 mg. Therefore, the objective of our planned study is to compare the analgesic efficacy of ibuprofen in the forms of 400 mg and 800 mg, which can be administered as a single dose, in the treatment of acute mechanical low back pain, as recommended in all guidelines.

Conditions

  • Low Back Pain, Mechanical
  • Ibuprofen
  • Analgesia
  • Pain Management

Interventions

DRUG

Ibuprofen 400 mg

Patients will receive ibuprofen 400 mg/4 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl).

DRUG

Ibuprofen 800 mg

Patients will receive ibuprofen 800 mg/8 ml via the parenteral route as a rapid 10-minute infusion in 150 ml of saline solution (0.09% NaCl).

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Principal Investigators

  • SAFA DÖNMEZ, M.D. · Ankara City Hospital Bilkent

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-12-31
Completion
2023-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06064175 on ClinicalTrials.gov