Oral Ketamine for Children with Chronic Pain: A Pilot Phase 1 Study - 22/06/13
, Michael P. McDermott, PhD 2, Heather R. Adams, PhD 3, Robert H. Dworkin, PhD 4, Charles Venuto, PharmD 5, Susan G. Fisher, PhD 6, James G. Dolan, MD 6, David N. Korones, MD 7, 8Abstract |
Objective |
To assess whether oral ketamine is safe at higher dosages for sedating children and whether it may be an option for the control of chronic pain in children.
Study design |
A prospective study was performed on 12 children with chronic pain to identify the maximum tolerated dosage of oral ketamine. Participants were given 14 days of oral ketamine, 3 times daily, at dosages ranging from 0.25-1.5 mg/kg/dose. Participants were assessed for toxicity and for pain severity at baseline and on day 14 of treatment.
Results |
Two participants, both treated at 1.5 mg/kg/dose, experienced dose-limiting toxicities (sedation and anorexia). One participant, treated at 1 mg/kg/dose, opted to stop ketamine treatment due to new pain on treatment. Nine participants completed their course of ketamine treatment. Of these 12 children, 5 experienced improvement in their pain scores, 2 with complete resolution of pain, lasting >4 weeks off ketamine treatment.
Conclusion |
Oral ketamine at dosages of 0.25-1 mg/kg/dose appears to be safe when given for 14 days to children with chronic pain.
Le texte complet de cet article est disponible en PDF.Keyword : AUC, CRM, CYP, DLT, DN4, NOS, NRS
Plan
| Supported by a University of Rochester CTSA award (UL1 RR024160 from the National Center for Research Resources and the National Center for Advancing Translational Sciences of the National Institutes of Health). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The authors declare no conflicts of interest. |
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| Registered with ClinicalTrials.gov: NCT01369680. |
Vol 163 - N° 1
P. 194 - juillet 2013 Retour au numéro
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