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The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.
The investigators enrolled 170 consecutive patients with femur fracture and severe pain. The patients received an initial analgesic treatment with paracetamol orally (OR) or intravenously (IV). The primary outcome was the reduction of pain of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). Secondary endpoints included the reduction of pain of at least 2 points on the VAS scale at the 4 th hour (T4), the need of rescue therapy and the number of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol IV | Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV). |
| |
| Paracetamol OR | Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | Paracetamol given orally or intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). | The Visual Analogue Scale for Pain (VAS) is a validated self-reported instrument that identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity) | Baseline and 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Pain change of at least 2 points on the VAS scale at the 4 th hour (T4) | identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity) | Baseline and 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with femur fracture admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
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| Name | Affiliation | Role |
|---|---|---|
| Francesco Franceschi | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli, IRCCS | Roma | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31388846 | Background | Dizdarevic A, Farah F, Ding J, Shah S, Bryan A, Kahn M, Kaye AD, Gritsenko K. A Comprehensive Review of Analgesia and Pain Modalities in Hip Fracture Pathogenesis. Curr Pain Headache Rep. 2019 Aug 6;23(10):72. doi: 10.1007/s11916-019-0814-9. | |
| 26614924 | Background | Gangavalli AK, Nwachuku CO. Management of Distal Femur Fractures in Adults: An Overview of Options. Orthop Clin North Am. 2016 Jan;47(1):85-96. doi: 10.1016/j.ocl.2015.08.011. |
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All IPD that underlie results of the publication
The data will be available immediately and ending 3 years after the publication of the study.
Proposals should be directed to francesco.franceschi@policlinicogemelli.it. To gain access, requestors will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D010146 | Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D007869 | Leg Injuries |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| 30377550 | Result | Dixon J, Ashton F, Baker P, Charlton K, Bates C, Eardley W. Assessment and Early Management of Pain in Hip Fractures: The Impact of Paracetamol. Geriatr Orthop Surg Rehabil. 2018 Oct 25;9:2151459318806443. doi: 10.1177/2151459318806443. eCollection 2018. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| Aniline Compounds |
| D000588 | Amines |