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

NCT06064175 | Completed Phase 4

• 1 other identifier: Low Back Pain Analgesic
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• NRS

  Numeric Rating Scale

  15., 30., 60. and 120. minutes

Study Arms (2)

Ibuprofen 400 mg-group 1

EXPERIMENTAL

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 400 mg

Ibuprofen 800 mg-group 2

EXPERIMENTAL

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).

Drug: Ibuprofen 800 mg

Interventions

Ibuprofen 400 mg DRUG

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).

Ibuprofen 400 mg-group 1

Ibuprofen 800 mg DRUG

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).

Ibuprofen 800 mg-group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 and above but under 65 years old.
• Patients willing to participate in the study.
• Patients with acute pain lasting less than two weeks.
• Non-traumatic pain.
• Patients without radicular back pain.
• Patients scoring more than 5 points on the 24-item validated Roland Morris Disability Questionnaire (RMDQ).
• Patients marking more than 4 on the Numeric Pain Rating Scale (NRS).
• Patients deemed appropriate for the study by an emergency medicine specialist based on history and physical examination.
• Patients in whom other differential diagnoses are not primarily considered.

You may not qualify if:

• \- Patients aged below 18 and above 65.
• Patients who decline to participate in the study.
• Patients with vital signs outside normal limits.
• Patients with a history of adverse reactions to ibuprofen.
• Patients unable to determine their pain intensity on the NRS.
• Pregnant individuals.
• Individuals with a history of heart disease and hypertension.
• Individuals with advanced systemic diseases.
• Patients with malignancies.
• Patients with chronic liver disease.
• Individuals using neuro-psychiatric drugs with sedative and analgesic effects.
• Individuals with a history of psychological and neurological diseases.
• Patients who used analgesics within 6 hours before examination.
• Patients with pain lasting more than two weeks.
• Traumatic cases.

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital

Ankara, 06800, Turkey (Türkiye)

Location

Related Publications (5)

• Oliveira IS, Vanin AA, Pena Costa LO, Medeiros FC, Ananias Oshima RK, Inacio AA, Matos da Cunha TA, Palomo AS, Fukuda TY, de Freitas DG, Benvenuto F, Menezes Costa LDC. Profile of Patients With Acute Low Back Pain Who Sought Emergency Departments: A Cross-sectional Study. Spine (Phila Pa 1976). 2020 Mar 1;45(5):E296-E303. doi: 10.1097/BRS.0000000000003253.

  PMID: 32045404 BACKGROUND

• Ostojic P, Radunovic G, Lazovic M, Tomanovic-Vujadinovic S. Ibuprofen plus paracetamol versus ibuprofen in acute low back pain: a randomized open label multicenter clinical study. Acta Reumatol Port. 2017 Jan-Mar;42(1):18-25.

  PMID: 27978532 BACKGROUND

• Friedman BW, Irizarry E, Chertoff A, Feliciano C, Solorzano C, Zias E, Gallagher EJ. Ibuprofen Plus Acetaminophen Versus Ibuprofen Alone for Acute Low Back Pain: An Emergency Department-based Randomized Study. Acad Emerg Med. 2020 Mar;27(3):229-235. doi: 10.1111/acem.13898. Epub 2020 Jan 7.

  PMID: 31811673 BACKGROUND

• Pohjolainen T, Jekunen A, Autio L, Vuorela H. Treatment of acute low back pain with the COX-2-selective anti-inflammatory drug nimesulide: results of a randomized, double-blind comparative trial versus ibuprofen. Spine (Phila Pa 1976). 2000 Jun 15;25(12):1579-85. doi: 10.1097/00007632-200006150-00019.

  PMID: 10851109 BACKGROUND

• Tuzun F, Unalan H, Oner N, Ozguzel H, Kirazli Y, Icagasioglu A, Kuran B, Tuzun S, Basar G. Multicenter, randomized, double-blinded, placebo-controlled trial of thiocolchicoside in acute low back pain. Joint Bone Spine. 2003 Sep;70(5):356-61. doi: 10.1016/s1297-319x(03)00075-7.

  PMID: 14563464 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Agnosia

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• SAFA DÖNMEZ, M.D.

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: September 26, 2023
• First Posted: October 3, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 1, 2023
• Last Updated: October 3, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)