Rib Fracture
Conditions
Keywords
ibuprofen, rib fracture, dexketoprofen, analgesia, emergency department
Brief summary
The purpose of this study is to compare the pain-relieving effects of two different nonsteroidal anti-inflammatory drugs (NSAIDs), intravenous ibuprofen and intravenous dexketoprofen, in adults who present to the emergency department with isolated rib fractures. Patients with rib fractures confirmed by a computed tomography (CT) scan and experiencing moderate to severe pain will randomly receive either 800 mg of intravenous ibuprofen or 50 mg of intravenous dexketoprofen. The researchers will measure pain levels using a 100-mm Visual Analog Scale (VAS) before the treatment and at 30, 60, and 120 minutes after receiving the medication to evaluate which drug provides better pain relief. The study will also track how many patients require additional rescue pain medication and record any side effects that occur during the observation period.
Detailed description
This is a single-center, prospective, randomized, single-blind controlled clinical trial conducted in an emergency department setting. The primary objective is to evaluate the absolute pain reduction from baseline to 60 minutes in patients receiving either intravenous ibuprofen 800 mg or intravenous dexketoprofen 50 mg for isolated rib fractures. Eligible adult patients with CT-confirmed isolated rib fractures after blunt thoracic trauma will be randomized in a 1:1 ratio using sequentially drawn treatment envelopes prepared prior to recruitment. Patients in the ibuprofen group will receive intravenous ibuprofen 800 mg mixed in 150 mL of 0.9% sodium chloride, and patients in the dexketoprofen group will receive intravenous dexketoprofen 50 mg mixed in 150 mL of 0.9% sodium chloride. Both treatments will be administered over a period of 5 to 10 minutes. Pain intensity will be self-reported by each patient using a 100-mm Visual Analog Scale (VAS), where 0 mm represents no pain and 100 mm represents the worst imaginable pain. Assessments will occur at baseline (0 minutes) and at 30, 60, and 120 minutes post-treatment. At the 60-minute evaluation, patients who still report a VAS score of 50 mm or greater, or those whose analgesia is considered inadequate by the treating physician, will be given a rescue analgesic consisting of tramadol hydrochloride 100 mg in 500 mL of 0.9% sodium chloride administered over 30 minutes. Patients who receive rescue analgesia will remain in the study and complete their final 120-minute VAS assessment. All observed adverse events during the study timeframe will be recorded prospectively.
Interventions
800 mg of intravenous ibuprofen in 150 mL of 0.9% sodium chloride over 5-10 minutes.
50 mg of intravenous dexketoprofen in 150 mL of 0.9% sodium chloride over 5-10 minutes.
Sponsors
Study design
Eligibility
Inclusion criteria
Aged 18 years or older Presence of an isolated rib fracture after blunt thoracic trauma confirmed by non-contrast thoracic computed tomography A baseline Visual Analog Scale (VAS) pain score of at least 50 mm A Glasgow Coma Scale (GCS) score of 15 Stable vital signs
Exclusion criteria
Known NSAID allergy or intolerance Pregnancy or breastfeeding Analgesic or sedative use within the preceding 12 hours Inability to complete VAS assessment because of cognitive or neuropsychiatric impairment Advanced chronic systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute pain reduction from baseline to 60 minutes (ΔVAS0-60) | Baseline and 60 minutes | Pain intensity assessed using a 100-mm Visual Analog Scale (VAS) anchored by 0 mm (no pain) and 100 mm (worst imaginable pain). Absolute pain reduction is calculated as baseline VAS minus the 60-minute VAS score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain reduction at 30 minutes | Baseline and 30 minutes | Absolute and relative pain reduction calculated using the 100-mm VAS score at 30 minutes compared to baseline. |
Countries
Turkey (Türkiye)