The effect of ketorolac on posterior thoracolumbar spinal fusions: a prospective double-blinded randomised placebo-controlled trial protocol.

Anti-Inflammatory Agents, Non-Steroidal / administration & dosage Double-Blind Method Humans Ketorolac / administration & dosage Length of Stay Multicenter Studies as Topic Pain Measurement Pain, Postoperative / drug therapy Prospective Studies Randomized Controlled Trials as Topic Spinal Fusion / adverse effects Treatment Outcome
ketorolac lumbar non-steroidal anti-inflammatory drugs opioids pseudoarthrosis spinal fusion

Journal

BMJ open
ISSN: 2044-6055
Titre abrégé: BMJ Open
Pays: England
ID NLM: 101552874

Informations de publication

Date de publication:
21 01 2019
Historique:
entrez: 24 1 2019
pubmed: 24 1 2019
medline: 20 2 2020
Statut: epublish

Résumé

Ketorolac has been shown to provide quality postoperative pain control and decrease opioid requirement with minimal side effects following spinal surgery. However, the literature addressing its use in spinal fusions is highly variable in both its effectiveness and complications, such as pseudarthrosis. Recent literature postulates that ketorolac may not affect fusion rates and large randomised controlled trials are needed to demonstrate ketorolac as a safe and effective adjuvant treatment to opioids for postoperative pain control. This is a multihospital, prospective, double-blinded, randomised placebo-controlled trial. Data concerning fusion rates, postoperative opioid use, pain scores, length of stay will be recorded with the aim of demonstrating that the use of ketorolac does not decrease thoracolumbar spinal fusion rates while identifying possible adverse events related to short-term minimal effective dose compared with placebo. Additionally, this investigation aims to demonstrate a decrease in postoperative opioid use demonstrated by a decrease in morphine equivalence while showing equivalent postoperative pain control and decrease the average length of stay. Ethical approval was obtained at all participating hospitals by the institutional review board. The results of this study will be submitted for publication in peer-reviewed journals. NCT03278691.

Identifiants

DOI: 10.1136/bmjopen-2018-025855 PMID: 30670528 PMC: PMC6347897
pubmed: 30670528
pii: bmjopen-2018-025855
doi: 10.1136/bmjopen-2018-025855
pmc: PMC6347897
doi:

Substances chimiques

Anti-Inflammatory Agents, Non-Steroidal 0
Ketorolac YZI5105V0L

Banques de données

ClinicalTrials.gov
['NCT03278691']

Types de publication

Clinical Trial Protocol Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

e025855

Informations de copyright

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Déclaration de conflit d'intérêts

Competing interests: None declared.

Références

Spine (Phila Pa 1976). 2001 Aug 1;26(15):1656-61
pubmed: 11474350
J Bone Joint Surg Am. 2004 Jan;86(1):116-23
pubmed: 14711953
J Postgrad Med. 2009 Apr-Jun;55(2):131-4
pubmed: 19550060
J Bone Joint Surg Am. 2007 Jan;89(1):114-25
pubmed: 17200318
Can J Anaesth. 2005 May;52(5):506-12
pubmed: 15872130
Neurosurg Focus. 2015 Oct;39(4):E10
pubmed: 26424334
Spine (Phila Pa 1976). 1996 Aug 15;21(16):1870-6
pubmed: 8875718
Acta Orthop Scand. 1980 Aug;51(4):595-600
pubmed: 7446048
Reg Anesth. 1997 Jul-Aug;22(4):343-6
pubmed: 9223200
Yonsei Med J. 2005 Apr 30;46(2):245-51
pubmed: 15861498
J Bone Joint Surg Am. 2007 Mar;89(3):500-11
pubmed: 17332098
J Bone Joint Surg Am. 2002 Oct;84(10):1763-8
pubmed: 12377905
Spine J. 2003 Jan-Feb;3(1):55-62
pubmed: 14589246
Anesth Analg. 1998 Jul;87(1):98-102
pubmed: 9661554
Spine (Phila Pa 1976). 1986 Nov;11(9):942-3
pubmed: 3824072
J Pharmacol Toxicol Methods. 2000 Jan-Feb;43(1):31-9
pubmed: 11091128
Spine (Phila Pa 1976). 1998 Apr 1;23(7):834-8
pubmed: 9563116
Spine (Phila Pa 1976). 1997 Jan 15;22(2):210-9; discussion 219-20
pubmed: 9122804
J Orthop Trauma. 2005 Nov-Dec;19(10):717-23
pubmed: 16314720
Spine (Phila Pa 1976). 2001 Mar 1;26(5):538-43; discussion 543-4
pubmed: 11242382
Spine (Phila Pa 1976). 1991 Jun;16(6 Suppl):S261-5
pubmed: 1862422
Spine J. 2009 May;9(5):343-9
pubmed: 18790686
J Bone Miner Res. 2002 Jun;17(6):963-76
pubmed: 12054171
Clin Spine Surg. 2018 Mar;31(2):65-72
pubmed: 29351095
J Neurosurg Spine. 2007 Dec;7(6):631-6
pubmed: 18074688
Spine (Phila Pa 1976). 2001 Apr 15;26(8):933-9
pubmed: 11317116
J Bone Joint Surg Am. 2003 Apr;85(4):632-4
pubmed: 12672837
Spine (Phila Pa 1976). 2011 Apr 1;36(7):E461-8
pubmed: 20489674
Pharmacology. 1998 Sep;57(3):148-59
pubmed: 9691235
Acta Anaesthesiol Belg. 1993;44(4):141-7
pubmed: 7906911
Br J Anaesth. 1992 Jul;69(1):19-22
pubmed: 1303630
J Orthop Res. 2003 Jul;21(4):670-5
pubmed: 12798067
J Orthop Trauma. 2016 Sep;30(9):479-82
pubmed: 27124828
Spine (Phila Pa 1976). 2008 May 1;33(10):1119-24
pubmed: 18449047
Clin Orthop Relat Res. 1995 Apr;(313):270-8
pubmed: 7641490
Spine (Phila Pa 1976). 2008 Sep 1;33(19):2079-82
pubmed: 18698276
JAMA Intern Med. 2017 May 1;177(5):611-612
pubmed: 28288245
Anesth Analg. 2001 Jun;92(6):1473-6
pubmed: 11375828
Acta Orthop Scand. 1992 Jun;63(3):330-3
pubmed: 1609602
Spine (Phila Pa 1976). 1999 Nov 1;24(21):2188-93; discussion 2193-4
pubmed: 10562982
Spine (Phila Pa 1976). 2014 Oct 1;39(21):1765-70
pubmed: 25054650
J Neurosurg Spine. 2014 Jul;21(1):23-30
pubmed: 24980581
Acta Ortop Mex. 2011 May-Jun;25(3):156-60
pubmed: 22512110
J Pain. 2017 Apr;18(4):360-365
pubmed: 27919771
Acta Orthop Scand. 1985 Feb;56(1):25-7
pubmed: 3920862
Spine (Phila Pa 1976). 1988 May;13(5):566-9
pubmed: 3187702

Auteurs

Chad F Claus (CF)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.
ORCID: 0000-0002-2523-8811

Evan Lytle (E)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Doris Tong (D)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Diana Sigler (D)

Department of Pharmacy, Ascension Providence Hospital, Southfield, Michigan, USA.

Dominick Lago (D)

Division of Neuro-anesthesia, Department of Anesthesia, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Matthew Bahoura (M)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Amarpal Dosanjh (A)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Michael Lawless (M)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Dejan Slavnic (D)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Prashant Kelkar (P)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Clifford Houseman (C)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Peter Bono (P)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Boyd Richards (B)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

Teck M Soo (TM)

Division of Neurosurgery, Department of Surgery, Ascension Providence Hospital, Michigan State University, College of Human Medicine, Southfield, Michigan, USA.

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Classifications MeSH

questionsmedicales.fr › Actions chimiques et utilisations › Actions pharmacologiques › Utilisations thérapeutiques › Antirhumatismaux › Anti-inflammatoires non stéroïdiens › The effect of ketorolac on posterior...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Méthodologie en recherche épidémiologique › Méthode en double aveugle › The effect of ketorolac on posterior...
questionsmedicales.fr › Eucaryotes › Animaux › Chordés › Vertébrés › Mammifères › Eutheria › Primates › Haplorhini › Catarrhini › Hominidae › Humains › The effect of ketorolac on posterior...
questionsmedicales.fr › Composés hétérocycliques › Composés hétérocycliques à cycles fusionnés › Composés hétérobicycliques › Indoles › Indométacine › Kétorolac › The effect of ketorolac on posterior...
questionsmedicales.fr › Établissements, main d'oeuvre et services de soins de santé › Services de santé › Soins aux patients › Hospitalisation › Durée du séjour › The effect of ketorolac on posterior...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études multicentriques comme sujet › The effect of ketorolac on posterior...
questionsmedicales.fr › Diagnostic › Techniques et procédures diagnostiques › Examen physique › Examen neurologique › Mesure de la douleur › The effect of ketorolac on posterior...
questionsmedicales.fr › États, signes et symptômes pathologiques › Signes et symptômes › Manifestations neurologiques › Douleur postopératoire › The effect of ketorolac on posterior...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études épidémiologiques › Études de cohortes › Études prospectives › The effect of ketorolac on posterior...
questionsmedicales.fr › Environnement et santé publique › Santé publique › Méthodes épidémiologiques › Caractéristiques des études épidémiologiques › Études cliniques comme sujet › Essais cliniques comme sujet › Essais cliniques contrôlés comme sujet › Essais contrôlés randomisés comme sujet › The effect of ketorolac on posterior...
questionsmedicales.fr › Procédures de chirurgie opératoire › Procédures orthopédiques › Arthrodèse › Arthrodèse vertébrale › The effect of ketorolac on posterior...
questionsmedicales.fr › Qualité, accès, évaluation des soins de santé › Qualité des soins de santé › Mécanismes d'évaluation des soins de santé › Évaluation des résultats et des processus en soins de santé › Évaluation de résultat (soins) › Résultat thérapeutique › The effect of ketorolac on posterior...