Buprenorphine for the Management of Pain in Children With Sickle Cell Disease

Summary

The goal of this clinical trial is to learn whether a single dose of buccal buprenorphine (BELBUCA) is safe when used in place and/or with full agonist opioids that would otherwise be started during a sickle cell pain crisis admission, in adolescents and young adults (ages 12-22) with sickle cell disease (SCD) who are hospitalized for acute pain. The main questions it aims to answer are: * Is a single dose of buccal buprenorphine, given at doses between 75 and 450 micrograms, safe in this population? * Does buccal buprenorphine reduce the amount of full agonist opioid pain medicine participants need through their patient-controlled analgesia (PCA) pump, and does it change pain scores? * Are participants and their care team satisfied with pain management when buccal buprenorphine is used? * What are the pharmacokinetic properties (how the body absorbs, distributes, and clears the drug) of buccal buprenorphine in this age group? This is a single-arm, open-label, dose-escalation study: every participant receives buccal buprenorphine, and there is no placebo or separate comparison group. Instead, researchers will compare each participant's own opioid use and pain scores in the 8 hours before receiving buccal buprenorphine to the 8 hours afterward, to see whether the dose reduces the need for additional opioid pain medicine. Participants will: * Be treated first with standard-of-care patient-controlled analgesia (PCA) pain medicine (hydromorphone) during the early, acute-stabilization phase of their hospital stay. * Once their pain is stable and they meet criteria to transition to oral opioids, as would happen under usual care, they will receive a single dose of buccal buprenorphine instead, at a dose (75, 150, 300, or 450 micrograms) assigned according to a dose-escalation design. * Continue to have access to demand-only PCA pain medicine for breakthrough pain after the study dose. * Undergo continuous monitoring of heart rate, oxygen level, and carbon dioxide level, plus pain and sedation checks every 4 hours, for 48 hours after the dose. * Have blood samples collected, only when blood is already being drawn for clinical care, to help study how the body processes the drug. * Complete a brief satisfaction survey about their pain management after the dose. * Be contacted by phone or telehealth, and have their medical record reviewed, 30 days after the dose to check for any safety concerns.

Timeline

Start

2026-10

Primary completion

2031-10

Completion

2032-10

Publications

• Background Carroll, Christopher Patrick, Elizabeth J. Prince, Ashley Lauriello, Lydia H. Pecker, and Sophie M. Lanzkron. "Acute Pain Treatment in Patients with Sickle Cell Disease Transitioned to Buprenorphine: Evidence of Equivalent Pain Relief." Journal of Sickle Cell Disease 2, no. 1 (2025): yoaf014. https://doi.org/10.1093/jscdis/yoaf014.
• Background Attina G, Romano A, Triarico S, Mastrangelo S, Maurizi P, Ruggiero A. Transdermal buprenorphine for pain management in children. Drugs Context. 2021 Sep 14;10:2021-6-1. doi: 10.7573/dic.2021-6-1. eCollection 2021.
• Background deBettencourt J, Nagy M, Rotman C, Greco C, Berde C, Archer NM. Buprenorphine for Children and Adolescents with Sickle Cell Disease: A Scoping Review. Children (Basel). 2026 Mar 10;13(3):388. doi: 10.3390/children13030388.
• Background Webster LR, Cater J, Smith T. Pharmacokinetics of Buprenorphine Buccal Film and Orally-administered Oxycodone in a Respiratory Study: An Analysis of Secondary Outcomes from a Randomized Controlled Trial. Pain Ther. 2022 Sep;11(3):817-825. doi: 10.1007/s40122-022-00380-2. Epub 2022 May 7.
• Background Walsh SL, Preston KL, Stitzer ML, Cone EJ, Bigelow GE. Clinical pharmacology of buprenorphine: ceiling effects at high doses. Clin Pharmacol Ther. 1994 May;55(5):569-80. doi: 10.1038/clpt.1994.71.
• Background Spinella S, McCarthy R. Buprenorphine for Pain: A Narrative Review and Practical Applications. Am J Med. 2024 May;137(5):406-413. doi: 10.1016/j.amjmed.2024.01.022. Epub 2024 Feb 9.

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