Ketamine and Hydromorphone PCA Analgesia for Antineoplastic-Induced Pediatric Mucositis
This research study looks at children receiving pain medicine (called hydromorphone) using Patient Controlled Analgesia (PCA) (a method where the patient can control their own pain relief medication) to treat the pain of oral mucositis (painful sores in the mouth often caused by cancer fighting drugs).
We would like to evaluate the effects of a combination of two drugs (ketamine and hydromorphone) on how they relieve the pain of mucositis. Neither ketamine nor hydromorphone are experimental medicines. We believe that the combination of these two medications will reduce the pain caused by mucositis.
Who can participate in this study?
- Your child is eligible for this study if there is oral mucositis resulting from chemotherapy (cancer treatment) and they are currently appropriately using PCA hydromorphone pain relief. Your child will have received a previous 12 hour average of greater than or equal to 4 mcg/kg/hour of PCA administered hydromorphone and have self-report pain scores of greater than 5/10 with swallowing. Your child must not be greatly overweight, must have an oxygen saturation (SpO2) of greater than 90% on room air, have a normal level of consciousness (arousal score of 5), and have the ability to understand the self-report symptom evaluation questionnaire.
Who should not participate in this study?
- Your child must not already be receiving simultaneous pain medicine or sedatives such as acetaminophen, gabapentin, lorazepam, nabilone or clonidine. Your child must not have previously participated in the trial. Your child must not have a mood or behavioural problem, high blood pressure or known allergy or previous adverse reaction to ketamine.
Status?
- Actively recruting subjects.
For more information, please see the Consent/Information form