Oral ketamine for children with chronic pain: a pilot phase 1 study

Abstract

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.

Trial registration: ClinicalTrials.gov NCT01369680.

Copyright © 2013 Mosby, Inc. All rights reserved.

Figures

Figure 1

CONSORT diagram of participants approached and treated.

Figure 2

Concentration-time curve and estimated pharmacokinetic parameters for norketamine by participant.

Figure 3

NRS pain scores at baseline and at the end of ketamine treatment for all participants. If the participant did not complete 14 days of treatment, their pain score at completion is noted (1009, 1010, 1012). Otherwise, the pain score is for the Day 14 visit.