Ruggiero, A., Coccia, P., Arena, R., Maurizi, P., Battista, A., Ridola, V., . . . Riccardi, R. (2013). Efficacy and safety of transdermal buprenorphine in the management of children with cancer-related pain. Pediatric Blood & Cancer, 60, 433–437.

To investigate the safety and efficacy of transdermal buprenorphine in the treatment of chronic cancer pain in children

Patients receiving other analgesics were transitioned to transdermal buprenorphine. The initial dose was 8.75–35 mcg/hour, depending on body weight. Patches were changed every three days. If needed, the dose could be titrated by means of a standard scheme. Study evaluations were done on days 4, 7, 14, 30, 44, and 60. Rescue medication, tramadol 1–2 mg/kg for breakthrough pain, was allowed as needed but not more than twice daily. School-age children self-reported study measures. Parents reported measures related to younger children.

• The sample was composed of 16 patients.
• Mean patient age was 11.06 years. Age range was 2–17 years.
• Of all patients, 56.3% were male and 43.7% were female.
• Patients had various tumor types; most were central nervous system tumors, bone sarcomas, and lymphomas. Of all patients, 75% had metastasis, 87.5% had had chemotherapy, and 75% had had surgery. Patients had not undergone previous opioid treatment and had moderate to severe pain—that is, pain measuring 6 or higher on the visual analog scale—that was not satisfactorily controlled.

• Single site
• Outpatient
• Italy

Clinical application: pediatrics

Prospective observational study

• Wong-Baker FACES Pain Rating Scale
• Four-point scale, to measure sleep quality
• Three-point scale, to measure level of play, alimentation, speech, and activity
• Scale measuring global assessment of treatment efficacy
• Use of rescue medication
• Four-point scale, to measure adverse events
• Response (response = pain intensity score reduction of at least 2 and use of rescue medication no more than twice daily)

• After two weeks, 68.75% of patients responded to transdermal buprenorphine treatment.
• Over the course of the study, pain intensity declined from 6.35 ± 0.68 at baseline to 1.38 ± 1.89 at day 60 (p < 0.001).
• Quality of sleep, alimentation, play, and speech improved over time (p < 0.001). 
• By week 4, 40% fewer patients required rescue medication.
• Overall efficacy and patient compliance were positive.
• Authors rated tolerability as good or very good in 100% of patients by the end of the study. Of all patients, 100% rated efficacy as good or excellent.
• The most common adverse effects were nausea, vomiting, and constipation.
• Mean buprenorphine dose was 32.6 ± 14.78 mcg/hour; the dose range was 0.5–1.8 mcg/kg/hour.

Transdermal buprenorphine was effective at treating chronic cancer-related pain in pediatric patients. Patients tolerated the drug well.

• The study had a small sample, with fewer than 30 patients.
• The study had risks of bias due to no control group, no blinding, and no random assignment.
• Authors did not describe means of measurement or methods well.
• Rating scales were not evaluated.
• Investigators, not patients, rated tolerability.

Findings suggest that pediatric patients can safely use transdermal buprenorphine and that it is effective at treating the pain of the specified patients. Nurses should be aware that these findings resulted from a study with a very small sample; the findings may not reflect actual frequency of adverse events. Pediatric patients should be closely monitored for adverse events. The side effects of transdermal buprenorphine in children are the effects typical of opioids; care should include a prophylactic approach to side effect management.