Intravenous Acetaminophen as Adjuvant Therapy for Pain Control in Geriatric Hip Fracture Patients
29 septembre 2014 mis à jour par: Michael A. Horst, PhD, MPHS, MS, Lancaster General Hospital
This research study is a prospective, randomized, blinded, placebo controlled trial evaluating the benefit of IV acetaminophen (Ofirmev™) as adjuvant analgesia in geriatric hip fracture patients.
IV acetaminophen has received FDA approval.
IV acetaminophen does not have the liver toxicity as oral acetaminophen.
No oral acetaminophen will be administered.
All patients diagnosed with a hip fracture aged at least 65 years and expected to undergo surgical intervention are eligible to participate.
Hip fractures affect greater than 300,000 geriatric patients annually, representing the second leading cause of hospitalization for this patient population.
Pain control in these patients is often problematic due to co-morbidities and changes in their pharmacokinetic and pharmacodynamic profiles.
Subjects may receive the normal DVT prophylactic treatments post-op.
Aperçu de l'étude
Statut
Retiré
Les conditions
Intervention / Traitement
Description détaillée
Approximately 46 subjects will be enrolled at LGH. Subjects will be randomized 1:1 to receive either IV acetaminophen 1000 mg q6 hours (FDA recommended dose) or IV placebo.
While receiving the study drug/placebo the subject's blood pressure, heart rate, respiratory rate, & pain intensity will be monitored.
Additional pain meds will be given if needed.
Study treatment will continue until subject is taken into the operating room; at that time the intervention will be discontinued and other pain medication will be provided.
Participation in the study will end at time of discharge from the hospital.
Researchers are expecting a 33% decrease in opioid use for subjects randomized to treatment group.
Type d'étude
Interventionnel
Phase
- Phase 3
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Pennsylvania
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Lancaster, Pennsylvania, États-Unis, 17604
- Lancaster General Hospital
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- All patients aged at least 65 years with a diagnosis of hip fracture with whom surgical intervention is expected
- Patients with the following surgeons ( David Hughes MD, Gerald Rothacker MD, Frank Essis MD, James Carson MD, Michael Gish MD, Vincent Battista MD)
Exclusion Criteria:
- Documented drug or alcohol addiction or abuse
- Documented serum sodium levels > 145 mmol/L
- Documented serum chloride levels > 107 mmol/L
- Impaired liver function defined as an ALT or AST > 3 times the upper limit of normal, Child-Pugh class C, or patients with documented active liver disease
- Known allergy or intolerance to acetaminophen
- Weight ≤ 50 kg
- Creatinine clearance (CrCl) ≤ 30 ml/min as determined by the Cockcroft-Gault equation
- Documented dementia
- Acetaminophen (> 650 mg) or opioid (> 7 mg IV morphine equivalence) use within the previous 24 hours
- Documented chronic opioid use
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: Placebo
For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min).
A beyond use expiration of 6 hours will be placed on the container.
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For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min).
A beyond use expiration of 6 hours will be placed on the container.
All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia.
The treatment period will begin after admission and randomization, and will continue until surgical intervention.
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Comparateur actif: Acetaminophen treatment
For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min).
A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer.
|
For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min).
A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer.
All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia.
The treatment period will begin after admission and randomization, and will continue until surgical intervention.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Opioid usage
Délai: 24 Hours
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Participants will be assessed for opioid utilization until they go to surgery: an average of 24 hours.
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24 Hours
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Length of stay
Délai: Up to 1 week
|
Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
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Up to 1 week
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Vital signs
Délai: Up to 1 week
|
Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
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Up to 1 week
|
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Pain scores
Délai: Up to 1 week
|
Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
|
Up to 1 week
|
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Opioid induced side effects
Délai: Up to 1 week
|
Participants will be followed for the duration of their hospital stay, an expected average of 1 week.
Length of stay, vital signs (blood pressure, heart rate, respiratory rate), pain scores using the visual analog scale (VAS), and opioid induced side effects including: nausea, vomiting, changes in blood pressure and delirium
|
Up to 1 week
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Jennifer L Costello, PharmD, Lancaster General Hospital
- Chercheur principal: Gerald W Rothacker, MD, Lancaster General Hospital
- Chercheur principal: Jason Hall, PharmD, Lancaster General Hospital
- Chercheur principal: Jill Rebuck, PharmD, Lancaster General Hospital
- Chercheur principal: Michael A Horst, PhD, Lancaster General Hospital
- Chercheur principal: Melody Dillman, RN, Lancaster General Hospital
- Chercheur principal: Michael Gish, MD, Lancaster General Hospital
- Chercheur principal: Vincent Batista, MD, Lancaster General Hospital
- Chercheur principal: James H Carson, MD, Lancaster General Hospital
- Chercheur principal: Frank M Essis, MD, Lancaster General Hospital
- Chercheur principal: David P Hughes, MD, Lancaster General Hospital
- Chercheur principal: Heidi L Testa, RN, Lancaster General Hospital
- Chercheur principal: LouAnne Kruse, RN, Lancaster General Hospital
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Pettersson PH, Jakobsson J, Owall A. Intravenous acetaminophen reduced the use of opioids compared with oral administration after coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 2005 Jun;19(3):306-9. doi: 10.1053/j.jvca.2005.03.006.
- Chau DL, Walker V, Pai L, Cho LM. Opiates and elderly: use and side effects. Clin Interv Aging. 2008;3(2):273-8. doi: 10.2147/cia.s1847.
- Singla N, Pong A, Newman K; MD-10 Study Group. Combination oxycodone 5 mg/ibuprofen 400 mg for the treatment of pain after abdominal or pelvic surgery in women: a randomized, double-blind, placebo- and active-controlled parallel-group study. Clin Ther. 2005 Jan;27(1):45-57. doi: 10.1016/j.clinthera.2005.01.010.
- Morrison SR, Magaziner J, McLaughlin MA, Orosz G, Silberzweig SB, Koval KJ, Siu AL. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003 Jun;103(3):303-311. doi: 10.1016/S0304-3959(02)00458-X.
- Schuurmans MJ, Duursma SA, Shortridge-Baggett LM, Clevers GJ, Pel-Littel R. Elderly patients with a hip fracture: the risk for delirium. Appl Nurs Res. 2003 May;16(2):75-84. doi: 10.1016/s0897-1897(03)00012-0.
- Sinatra RS, Jahr JS, Reynolds LW, Viscusi ER, Groudine SB, Payen-Champenois C. Efficacy and safety of single and repeated administration of 1 gram intravenous acetaminophen injection (paracetamol) for pain management after major orthopedic surgery. Anesthesiology. 2005 Apr;102(4):822-31. doi: 10.1097/00000542-200504000-00019.
- Beaupre LA, Jones CA, Saunders LD, Johnston DW, Buckingham J, Majumdar SR. Best practices for elderly hip fracture patients. A systematic overview of the evidence. J Gen Intern Med. 2005 Nov;20(11):1019-25. doi: 10.1111/j.1525-1497.2005.00219.x.
- Abbott C. Falls and hip fractures [updated: February 2011]. University of Missouri-Columbia School of Health Professions. Available at: http://www.vhct.org/case4007/index.htm. Accessed September 26, 2011.
- Edelstein DM, Aharonoff GB, Karp A, Capla EL, Zuckerman JD, Koval KJ. Effect of postoperative delirium on outcome after hip fracture. Clin Orthop Relat Res. 2004 May;(422):195-200. doi: 10.1097/01.blo.0000128649.59959.0c.
- Baumann T, Strickland J. Pain Management. In:DiPiro JT, et al., editors. Pharmacotherpay. 7th ed. New York: McGraw-Hill;2008. 989-1002
- Ofirmev [package insert].San Diego, Ca: Cadence Pharmaceuticals; 2011
- Cattabriga I, Pacini D, Lamazza G, Talarico F, Di Bartolomeo R, Grillone G, Bacchi-Reggiani L. Intravenous paracetamol as adjunctive treatment for postoperative pain after cardiac surgery: a double blind randomized controlled trial. Eur J Cardiothorac Surg. 2007 Sep;32(3):527-31. doi: 10.1016/j.ejcts.2007.05.017. Epub 2007 Jul 23.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 décembre 2011
Achèvement primaire (Réel)
1 mai 2013
Achèvement de l'étude (Réel)
1 mai 2013
Dates d'inscription aux études
Première soumission
23 janvier 2012
Première soumission répondant aux critères de contrôle qualité
24 janvier 2012
Première publication (Estimation)
27 janvier 2012
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
30 septembre 2014
Dernière mise à jour soumise répondant aux critères de contrôle qualité
29 septembre 2014
Dernière vérification
1 septembre 2014
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2011-52 (Autre identifiant: CCRRC)
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