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This study evaluates whether adding a topical gel containing naproxen and lidocaine to routine intravenous analgesic treatment improves pain relief in adults with isolated traumatic rib fractures presenting to the emergency department. Participants are randomly allocated to receive either standard intravenous dexketoprofen alone or dexketoprofen combined with topical naproxen-lidocaine gel. Pain intensity is measured repeatedly during the first hour after treatment using the Numerical Rating Scale (NRS). The study also examines the need for additional rescue analgesia and monitors treatment-related adverse events to determine the effectiveness and safety of this multimodal analgesic strategy.
Pain caused by rib fractures frequently limits deep inspiration and coughing, potentially increasing the risk of respiratory complications. Although systemic analgesics remain the standard approach in the emergency department, combining medications with different mechanisms of action may provide superior pain control while reducing the need for additional analgesics. The present trial investigates whether topical administration of a naproxen-lidocaine gel offers additional analgesic benefit when used alongside routine intravenous NSAID therapy.
This investigation is designed as a prospective, randomized, controlled clinical trial conducted at a tertiary emergency department. Adults diagnosed with isolated rib fractures who meet predefined eligibility criteria are enrolled and randomly assigned to one of two treatment strategies. All participants receive intravenous dexketoprofen as standard care. Patients allocated to the intervention arm additionally receive topical application of a gel formulation containing naproxen and lidocaine over the painful rib fracture region, whereas the comparison group receives standard therapy alone.
Pain severity is evaluated using the Numerical Rating Scale before treatment and at predefined follow-up intervals during the first 60 minutes. The principal outcome is the magnitude of pain reduction achieved with each treatment strategy. Secondary outcome measures include the proportion of patients requiring rescue analgesic medication and the frequency of treatment-related adverse events. Statistical comparisons are planned to determine whether adjunctive topical therapy provides clinically meaningful improvements in early pain management for isolated traumatic rib fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intravenous dexketoprofen with gel combination of 10% naproxen and 5% lidocaine |
|
| Control | Active Comparator | Intravenous dexketoprofen (only) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard therapy + Intervention | Drug | Approximately 10 g of a topical gel containing 10% naproxen and 5% lidocaine was applied over the skin covering the fractured rib region, including the adjacent superior and inferior ribs, immediately after administration of intravenous dexketoprofen trometamol. The gel was applied once during the emergency department visit as an adjunct to standard systemic analgesic therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the decreases in NRS pain scores between two arms | Comparison of the absolute and relative (in percentage) changes in pain scores over time intervals | 0, 15, 30, 60.minutes and intervals between these time frames |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of the rescue analgesia need | Comparison of the rate of the rescue analgesia need between two arms | 60.minute |
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Inclusion Criteria:
Adults aged 18 years or older. Presentation to the emergency department following blunt chest trauma with isolated rib fracture(s) confirmed by clinical and/or radiological assessment.
A maximum of three fractured ribs. In cases of multiple fractures, involvement of adjacent (consecutive) ribs only.
No associated intrathoracic injuries, including pneumothorax, hemothorax, pulmonary contusion, or other clinically significant thoracic trauma.
Fully conscious and able to communicate effectively, with adequate orientation and cooperation to complete pain assessments.
Baseline Numerical Rating Scale (NRS) pain score ≥4 at the time of enrollment. Ability and willingness to provide written informed consent.
Exclusion Criteria:
Pregnancy or suspected pregnancy. Inability to reliably assess pain because of impaired consciousness, cognitive dysfunction, communication difficulties, or lack of cooperation.
Significant visual or hearing impairment interfering with study procedures. Use of systemic analgesic medication within 6 hours before enrollment. History of major psychiatric or neurological disorders that could influence pain perception or study participation.
Known hypersensitivity or previous adverse reaction to naproxen, lidocaine, dexketoprofen, tramadol hydrochloride, or any component of the study medications.
Presence of additional traumatic injuries requiring alternative pain management or hospital admission.
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| Name | Affiliation | Role |
|---|---|---|
| Alp Şener, Assoc Prof | Ankara Yildirim Beyazıt University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Bilkent City Hospital; Department of Emergency Medicine | Ankara | Çankaya | 06800 | Turkey (Türkiye) |
Individual participant data collected during this study will not be made publicly available. Requests for de-identified individual participant data may be considered by the corresponding author on a reasonable case-by-case basis, subject to ethical, legal, and institutional requirements.
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D012253 | Rib Fractures |
| D000377 | Agnosia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D013898 | Thoracic Injuries |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D008722 | Methods |
| D009288 | Naproxen |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
|
| Standard therapy (only) | Drug | Participants received 50 mg of intravenous dexketoprofen trometamol diluted in 150 mL of 0.9% sodium chloride solution and administered as a rapid intravenous infusion over approximately 15 minutes, according to the institution's standard analgesic protocol. |
|
|
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 | Investigative Techniques |
| D009280 | Naphthaleneacetic Acids |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |