Stability of Hydromorphone-Ketamine Solutions



Oral mucositis secondary to antineoplastic therapy is a challenging and severe pain problem in children. It typically requires parenteral opioid therapy, which is often administered by patient-controlled analgesia (PCA). The use of PCA for hydromorphone is standard practice at BC Children’s Hospital. However, this therapy is often only marginally effective, and it is associated with a high incidence of opioid- induced side effects such as dysphoria, nausea, sedation, and pruritus. Ketamine, an established IV analgesic commonly used in pediatrics, has demonstrated efficacy in the treatment of pediatric acute pain and oncologic pain when combined with opioid therapy at subanesthetic doses.

The goal of a planned observational pilot study at the authors’ institution is to evaluate the feasibility, efficacy, and optimum ratio of a compounded mixture of hydromorphone and ketamine administered parenterally by PCA to children with mucositis who have inadequate analgesia with conven­tional hydromorphone by PCA. For the planned study, the drug combination will be prepared as hydromorphone 0.2 mg/mL with a variable dose of ketamine (0.2, 0.6, or 1.0 mg/mL) in 100 mL of 0.9% sodium chloride (normal saline [NS]). To the authors’ knowledge, only one published study has evaluated the stability of the combination of hydro­morphone and ketamine in NS. Although those investigators tested the stability of 4 hydromorphone—ketamine concentration combinations in glass test tubes, the concentrations of interest for use in the pediatric population are notably lower than those previously reported. Furthermore, the authors of the current study were not aware of any stability testing data for hydromorphone—ketamine solutions stored in plastic syringes or IV bags. Thus, the objective of the current study was to evaluate the stability of hydromorphone—ketamine solutions, at 3 different concentration combinations commonly used in pediatric practice, prepared in NS and stored for a period of up to 7 days at room temperature in 3 different types of container (glass bottles, plastic syringes, and IV bags).
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