Clinical trial NCT04609254: Paracetamol, Dexketoprofen and Ibuprofen In Non-Traumatic Acute Low Back Pain
Official title: Comparison of The Effectiveness of Intravenous Paracetamol, Dexketoprofen and Ibuprofen In The Treatment of Non-Traumatic Acute Low Back Pain In The Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Low Back Pain, Mechanical
Keywords: paracetamol
dexketoprofen
ibuprofen
emergency department
low back pain
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2020-10-30
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* • Patients were eligible for inclusion if they were aged 18 years or older, 65 years or younger Isolated non traumatic musculoskeletal pain Patients who agree to work and receive the approval VAS (visual analog scale) score\>5.

Exclusion Criteria:

* • 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 cardiac chest pain
  * Patients with chronic pain
  * Patients with pre-existing ibuprofen, dexketoprofen and paracetamolinduced gastrointestinal bleeding and perforation
  * Patients with reflected pain
  * Patients with neoplastic pain
  * Patients with an allergy trait (ibuprofen, paracetamol and dexketoprofen)
  * Illiterates and patients with vision problems

Primary outcomes:
measure: Change From Baseline in Non-Traumatic Acute Low Back Pain on the Visual Analog Scale at 60 minutes
timeFrame: Baseline and 60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
affiliation: Pamukkale University
name: Cansu Dogan, MD
role: PRINCIPAL_INVESTIGATOR
References: