Femur FractureNCT05025228
Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?
An observational study of Femur Fracture, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femur Fracture
- What is being tested?
- Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 170 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jun 2019to 30 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with femur fracture admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Allergy to paracetamol
- Unable to take analgesic therapy both orally (OR) and intravenously (IV)
- Unable to define pain by VAS
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
Roma, 00168
About this study
The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.
Read the detailed description
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.
- Conditions
- Femur Fracture
- Being tested
- Paracetamol
- Keywords
- Femur Fracture, Pain, Paracetamol, Emergency Department
- Medical subject headings
- Femoral Fractures, Pain, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParacetamolDrug
Also called Acetaminophen, N-acetyl-para-aminophenol
Paracetamol given orally or intravenously
| Study group | Role | What they receive |
|---|---|---|
| Paracetamol IV | Patients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV). Receives: Drug: Paracetamol | |
| Paracetamol OR | Patients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR). Receives: Drug: Paracetamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and 1 hour
Secondary outcomes (1)
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)
Measured: Baseline and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start1 Jun 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (31)Papers the sponsor has linked to this study.
- Other trials for Femur FractureStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francesco Franceschi, Study director, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05025228
- Sponsor's protocol ID
- Prot. 36041/19 ID: 2727
- Status last verified
- Jun 2020
- First submitted
- 24 Aug 2021
- Last updated
- 11 Oct 2021
- Results posted
- No
- Individual data sharing
- Yes: All IPD that underlie results of the publication
Publications
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.
PubMed 31388846Gangavalli 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.
PubMed 26614924Glinkowski 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.
PubMed 31540458Soffin 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.
PubMed 31094775Fabi DW. Multimodal Analgesia in the Hip Fracture Patient. J Orthop Trauma. 2016 May;30 Suppl 1:S6-S11. doi: 10.1097/BOT.0000000000000561.
PubMed 27101321Elsoe 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.
PubMed 29116356Bonnin 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.
PubMed 26033052Lim 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.
PubMed 30039251Mattisson 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.
PubMed 30314495Roder 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.
PubMed 12540352Larsen 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.
PubMed 31081515Rowlands 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.
PubMed 29643155Uysal 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.
PubMed 31942744Oc 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.
PubMed 33101681Li 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.
PubMed 32845763
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effect of Paracetamol in Patients With Femur Fracture: is Intravenous Better Than Oral?
- ClinicalTrials.gov ID
- NCT05025228
- Acronym / sponsor ID
- Prot. 36041/19 ID: 2727
- Conditions
- Femur Fracture
- Keywords
- Femur Fracture, Pain, Paracetamol, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 27 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor severe pain for femur fracture after treatment with paracetamol IV or OR.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paracetamol IV | – | Drug: ParacetamolPatients with femur fracture that received an initial analgesic treatment with paracetamol intravenously (IV). |
| Paracetamol OR | – | Drug: ParacetamolPatients with femur fracture that received an initial analgesic treatment with paracetamol orally (OR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with femur fracture admitted to the ED of Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- Age <18 years
- Allergy to paracetamol
- Unable to take analgesic therapy both orally (OR) and intravenously (IV)
- Unable to define pain by VAS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParacetamolAlso: Acetaminophen, N-acetyl-para-aminophenolParacetamol given orally or intravenously | Drug | Paracetamol IV, Paracetamol OR |
Primary outcome
Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1).
Time frame: Baseline and 1 hour
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)
1 secondary outcome
Pain change of at least 2 points on the VAS scale at the 4 th hour (T4)
Time frame: Baseline and 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2021.
- Background: PubMed 31388846Dizdarevic 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.
- Background: PubMed 26614924Gangavalli 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.
- Background: PubMed 31540458Glinkowski 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.
- Background: PubMed 31094775Soffin 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.
- Background: PubMed 27101321Fabi DW. Multimodal Analgesia in the Hip Fracture Patient. J Orthop Trauma. 2016 May;30 Suppl 1:S6-S11. doi: 10.1097/BOT.0000000000000561.
- Background: PubMed 29116356Elsoe 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.
- Background: PubMed 26033052Bonnin 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.
- Background: PubMed 30039251Lim 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.
- Background: PubMed 30314495Mattisson 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.
- Background: PubMed 12540352Roder 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.
- Background: PubMed 31081515Larsen 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.
- Background: PubMed 29643155Rowlands 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.
- Individual participant dataSharing planned: Yes. All IPD that underlie results of the publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francesco Franceschi study director
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femur Fracture, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain change of 1 point at visual analogue scale for pain (VAS) after the 1 st hour of treatment (T1). (time frame: Baseline and 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05025228, which also lists 31 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2021.