Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?
8. oktober 2021 oppdatert av: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.
Studieoversikt
Detaljert beskrivelse
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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
170
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Patients with femur fracture admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Patients admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
- Femur Fracture
- Patients who signed the informed consent
- Able to take analgesic therapy both orally (OR) and intravenously (IV)
- Able to define pain by VAS
Exclusion Criteria:
- Age <18 years
- Allergy to paracetamol
- Unable to take analgesic therapy both orally (OR) and intravenously (IV)
- Unable to define pain by VAS
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Paracetamol IV
Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV).
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Paracetamol given orally or intravenously
Andre navn:
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Paracetamol OR
Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR).
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Paracetamol given orally or intravenously
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1).
Tidsramme: Baseline and 1 hour
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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)
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Baseline and 1 hour
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Pain change of at least 2 points on the VAS scale at the 4 th hour (T4)
Tidsramme: Baseline and 4 hours
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identifies pain from 0 to 10 (with 0 = no pain and 10 = maximum pain intensity)
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Baseline and 4 hours
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Francesco Franceschi, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
- Kanis JA, Oden A, McCloskey EV, Johansson H, Wahl DA, Cooper C; IOF Working Group on Epidemiology and Quality of Life. A systematic review of hip fracture incidence and probability of fracture worldwide. Osteoporos Int. 2012 Sep;23(9):2239-56. doi: 10.1007/s00198-012-1964-3. Epub 2012 Mar 15.
- Roder F, Schwab M, Aleker T, Morike K, Thon KP, Klotz U. Proximal femur fracture in older patients--rehabilitation and clinical outcome. Age Ageing. 2003 Jan;32(1):74-80. doi: 10.1093/ageing/32.1.74.
- Larsen P, Ceccotti AA, Elsoe R. High mortality following distal femur fractures: a cohort study including three hundred and two distal femur fractures. Int Orthop. 2020 Jan;44(1):173-177. doi: 10.1007/s00264-019-04343-9. Epub 2019 May 12.
- Uysal AI, Altiparmak B, Yasar E, Turan M, Canbek U, Yilmaz N, Gumus Demirbilek S. The effects of early femoral nerve block intervention on preoperative pain management and incidence of postoperative delirium geriatric patients undergoing trochanteric femur fracture surgery: A randomized controlled trial. Ulus Travma Acil Cerrahi Derg. 2020 Jan;26(1):109-114. doi: 10.14744/tjtes.2019.78002.
- 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.
- 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.
- Glinkowski W, Narloch J, Krasuski K, Sliwczynski A. The Increase of Osteoporotic Hip Fractures and Associated One-Year Mortality in Poland: 2008-2015. J Clin Med. 2019 Sep 18;8(9):1487. doi: 10.3390/jcm8091487.
- Soffin EM, Gibbons MM, Wick EC, Kates SL, Cannesson M, Scott MJ, Grant MC, Ko SS, Wu CL. Evidence Review Conducted for the Agency for Healthcare Research and Quality Safety Program for Improving Surgical Care and Recovery: Focus on Anesthesiology for Hip Fracture Surgery. Anesth Analg. 2019 Jun;128(6):1107-1117. doi: 10.1213/ANE.0000000000003925.
- Fabi DW. Multimodal Analgesia in the Hip Fracture Patient. J Orthop Trauma. 2016 May;30 Suppl 1:S6-S11. doi: 10.1097/BOT.0000000000000561.
- Elsoe R, Ceccotti AA, Larsen P. Population-based epidemiology and incidence of distal femur fractures. Int Orthop. 2018 Jan;42(1):191-196. doi: 10.1007/s00264-017-3665-1. Epub 2017 Nov 7.
- Bonnin MP, Neto CC, Aitsiselmi T, Murphy CG, Bossard N, Roche S. Increased incidence of femoral fractures in small femurs and women undergoing uncemented total hip arthroplasty - why? Bone Joint J. 2015 Jun;97-B(6):741-8. doi: 10.1302/0301-620X.97B6.35022.
- Lim SJ, Yeo I, Yoon PW, Yoo JJ, Rhyu KH, Han SB, Lee WS, Song JH, Min BW, Park YS. Incidence, risk factors, and fracture healing of atypical femoral fractures: a multicenter case-control study. Osteoporos Int. 2018 Nov;29(11):2427-2435. doi: 10.1007/s00198-018-4640-4. Epub 2018 Jul 23.
- Mattisson L, Bojan A, Enocson A. Epidemiology, treatment and mortality of trochanteric and subtrochanteric hip fractures: data from the Swedish fracture register. BMC Musculoskelet Disord. 2018 Oct 12;19(1):369. doi: 10.1186/s12891-018-2276-3.
- Rowlands M, Walt GV, Bradley J, Mannings A, Armstrong S, Bedforth N, Moppett IK, Sahota O. Femoral Nerve Block Intervention in Neck of Femur Fracture (FINOF): a randomised controlled trial. BMJ Open. 2018 Apr 10;8(4):e019650. doi: 10.1136/bmjopen-2017-019650.
- Oc Y, Varol A, Yazar EA, Ak S, Akpolat AO, Kilinc BE. Treatment strategy for elderly patients with the isolated greater trochanteric fracture. SAGE Open Med. 2020 Oct 7;8:2050312120964138. doi: 10.1177/2050312120964138. eCollection 2020.
- Li L, Bennett-Brown K, Morgan C, Dattani R. Hip fractures. Br J Hosp Med (Lond). 2020 Aug 2;81(8):1-10. doi: 10.12968/hmed.2020.0215.
- Makkar JK, Jain K, Kuberan A, Balasubramanian M, Bhatia N, Singh PM. Pre-emptive multimodal analgesic regimen reduces post-operative epidural demand boluses in traumatic shaft of femur fracture - A randomised controlled trial. Indian J Anaesth. 2019 Nov;63(11):895-899. doi: 10.4103/ija.IJA_363_19. Epub 2019 Nov 8.
- Chuang PY, Shen SH, Yang TY, Huang TW, Huang KC. Non-steroidal anti-inflammatory drugs and the risk of a second hip fracture: a propensity-score matching study. BMC Musculoskelet Disord. 2016 May 4;17:201. doi: 10.1186/s12891-016-1047-2.
- Franceschi F, Marsiliani D, Alesi A, Mancini MG, Ojetti V, Candelli M, Gabrielli M, D'Aurizio G, Gilardi E, Adducci E, Proietti R, Buccelletti F. A simplified way for the urgent treatment of somatic pain in patients admitted to the emergency room: the SUPER algorithm. Intern Emerg Med. 2015 Dec;10(8):985-92. doi: 10.1007/s11739-015-1304-7. Epub 2015 Sep 4.
- Di Filippo A, Magherini M, Ruggiano P, Ciardullo A, Falsini S. Postoperative analgesia in patients older than 75 years undergoing intervention for per-trochanteric hip fracture: a single centre retrospective cohort study. Aging Clin Exp Res. 2015 Jun;27(3):281-5. doi: 10.1007/s40520-014-0272-5. Epub 2014 Sep 17.
- Aprato A, Bechis M, Buzzone M, Bistolfi A, Daghino W, Masse A. No rest for elderly femur fracture patients: early surgery and early ambulation decrease mortality. J Orthop Traumatol. 2020 Aug 30;21(1):12. doi: 10.1186/s10195-020-00550-y.
- Mubark I, Abouelela A, Genena A, Al Ghunimat A, Sarhan I, Ashwood N. Mortality Following Distal Femur Fractures Versus Proximal Femur Fractures in Elderly Population: The Impact of Best Practice Tariff. Cureus. 2020 Sep 30;12(9):e10744. doi: 10.7759/cureus.10744.
- Piscitelli P, Neglia C, Feola M, Rizzo E, Argentiero A, Ascolese M, Rivezzi M, Rao C, Miani A, Distante A, Esposito S, Iolascon G, Tarantino U. Updated incidence and costs of hip fractures in elderly Italian population. Aging Clin Exp Res. 2020 Dec;32(12):2587-2593. doi: 10.1007/s40520-020-01497-0. Epub 2020 Feb 13.
- Guzon-Illescas O, Perez Fernandez E, Crespi Villarias N, Quiros Donate FJ, Pena M, Alonso-Blas C, Garcia-Vadillo A, Mazzucchelli R. Mortality after osteoporotic hip fracture: incidence, trends, and associated factors. J Orthop Surg Res. 2019 Jul 4;14(1):203. doi: 10.1186/s13018-019-1226-6.
- Peeters CM, Visser E, Van de Ree CL, Gosens T, Den Oudsten BL, De Vries J. Quality of life after hip fracture in the elderly: A systematic literature review. Injury. 2016 Jul;47(7):1369-82. doi: 10.1016/j.injury.2016.04.018. Epub 2016 Apr 23.
- Mian P, Allegaert K, Spriet I, Tibboel D, Petrovic M. Paracetamol in Older People: Towards Evidence-Based Dosing? Drugs Aging. 2018 Jul;35(7):603-624. doi: 10.1007/s40266-018-0559-x.
- Gazelka HM, Leal JC, Lapid MI, Rummans TA. Opioids in Older Adults: Indications, Prescribing, Complications, and Alternative Therapies for Primary Care. Mayo Clin Proc. 2020 Apr;95(4):793-800. doi: 10.1016/j.mayocp.2020.02.002.
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- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. juni 2019
Primær fullføring (Faktiske)
30. juni 2020
Studiet fullført (Faktiske)
30. juni 2020
Datoer for studieregistrering
Først innsendt
24. august 2021
Først innsendt som oppfylte QC-kriteriene
24. august 2021
Først lagt ut (Faktiske)
27. august 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. oktober 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. oktober 2021
Sist bekreftet
1. juni 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Prot. 36041/19 ID: 2727
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
All IPD that underlie results of the publication
IPD-delingstidsramme
The data will be available immediately and ending 3 years after the publication of the study.
Tilgangskriterier for IPD-deling
Proposals should be directed to francesco.franceschi@policlinicogemelli.it.
To gain access, requestors will need to sign a data access agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .