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The aim of this study is to evaluate the short-term effects of routinely applied agents on pain and joint range of motion (ROM) in ankle sprains presenting to the emergency department (ED).
It is aimed to examine the effects of intravenous (IV) 50 mg dexketoprofen, IV ibuprofen 400mg and IV paracetamol 10 mg on pain and joint range of motion. To determine the effects of these agents on pain, the easily applicable Numerical Rating Scale (NRS) and Wong-Baker Faces Pain Rating Scale will be used. A standard handheld half-circle goniometer will be utilized to calculate active ankle joint ROM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Dexketoprofen | Active Comparator | Dexketoprofen 50 mg will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
|
| Group Ibuprofen | Active Comparator | Ibuprofen 100 mg/ml will be administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
|
| Group Paracetamol | Active Comparator | Paracetamol 10 mg/ml will be administered parenterally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexketoprofen Trometamol 50 Mg/mL Solution for Injection | Drug | Dexketoprofen 50 mg administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains. | Numeric Rang Scale (NRS) will be used to assess effects on pain. NRS: This scale uses 11 numbers from 0 to 10 to measure pain intensity, where 0 represents "No pain" and 10 represents "Worst (unbearable) pain." | *Patient's pain level, NRS Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment |
| To evaluate the effectiveness of multimodal treatment methods on pain in ankle sprains. | Wong-Baker FACES pain rating scale (WBS) will be used to assess effects on pain. WBS: This scale uses a series of faces ranging from a smiling face representing "No pain" to a crying face representing "Worst pain" to visually express the intensity of pain. | *Wong-Baker Faces Pain Rating Scale: - 0 minute before treatment -15 minute after treatment -60 minute after treatment |
| To evaluate the effectiveness of multimodal treatment methods on Range of Motion in ankle sprains. | A standard handheld goniometer will be used to calculate Range of Motion (ROM) measurements. The aim is to determine the effects of multimodal treatment methods routinely applied in emergency services on pain and range of motion and to reveal their superiority over each other, if any. (Normal ROM values: 20° for dorsiflexion, 45° for plantar flexion) | - 0 minute ROM before treatment - 60 minute ROM after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet B. Erdem | Ankara Etlik City Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Ankara | Yenimahalle | 38000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D016512 | Ankle Injuries |
| ID | Term |
|---|---|
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D012996 | Solutions |
| D007267 | Injections |
| D007052 | Ibuprofen |
| D000082 | Acetaminophen |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Ibuprofen 100 MG/ML Solution for Injection | Drug | Ibuprofen 100 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). Group P: Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
|
| Paracetamol 10 Mg/mL Solution for Injection | Drug | Paracetamol 10 mg/ml administered parenterally (intravenously in 150 cc isotonic saline over 15 minutes infusion). |
|
| isotonic saline | Drug | Ibuprofen and dexketoprofen will be administered intravenously (IV) by mixing them into 150 cc of isotonic saline. |
|
| D010666 |
| Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |