NCT04609254

Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain

Comparison of The Effectiveness of Intravenous Paracetamol, Dexketoprofen and Ibuprofen In The Treatment of Non-Traumatic Acute Low Back Pain In The Emergency Department

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Pamukkale University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

* Currently, paracetamol and nonsteroidal antiinflammatory drugs are widely used by emergency physicians in Turkey for the treatment of patients with Non-Traumatic Acute Low Back Pain * The objective of the study is compare the efficacy of intravenous dexketoprofen,ibuprofen with paracetamol in the treatment of Non-Traumatic Acute Low Back Pain

Detailed description

* This is the randomized double blinded clinical trial to compare the efficacy of these three 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 and ibuprofen) 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 Non-Traumatic Acute Low Back 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 three groups: First Group: 1000 mg of paracetamol (parol 1000mg vial-atabay chemistry-İstanbul ) intravenous (IV) was given 71 patients, Second Group: dexketoprofen 50 mg ( arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients, third group: 400 mg İbuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 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,ibuprofen 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 Non-Traumatic Acute Low Back Pain scores. * Patients in three groups received three types of medication in a similar manner, thus ensuring double blind. Non-Traumatic Acute Low Back Pain scores were recorded at 0, 15, 30 and 60 min on a VAS of 1 to 100 • 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

• Low Back Pain, Mechanical

Interventions

Type	Name	Description
DRUG	Paracetamol	1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,
DRUG	Dexketoprofen	dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,
DRUG	Ibuprofen	400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.

Timeline

• Start date: 2018-12-15
• Primary completion: 2020-04-15
• Completion: 2020-09-15
• First posted: 2020-10-30
• Last updated: 2020-10-30

Locations

1 site across 1 country: Turkey (Türkiye)