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.

Conditions

• Sickle Cell Disease (SCD)
• Sickle Cell Disease Vaso-occlusive Crisis
• Sickle Cell Anemia Crisis
• Sickle Cell Anemia in Children
• Sickle Cell Anemia (HbSS, or HbSβ-thalassemia0)
• Sickle Cell Hemoglobin C Disease
• Pain Crisis

Interventions

DRUG

Buprenorphine Buccal Film [Belbuca]

A single buccal dose of buprenorphine (BELBUCA), administered once between 8:00 AM and 3:00 PM on the qualifying study day. Dose is assigned by dose-escalation cohort (75 mcg, 150 mcg, 300 mcg, or 450 mcg) per a Bayesian Optimal Interval (BOIN) design targeting a dose-limiting toxicity rate of 0.25.

Sponsors & Collaborators

• Natasha Archer

  lead OTHER

Principal Investigators

• Natasha Archer, MD · Dana-Farber/Boston Children's Cancer and Blood Disorders Center

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

12 Years

Max Age

22 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-10-31

Primary Completion

2031-10-31

Completion

2032-10-31

FDA Drug

Yes

Countries

• United States

Study Locations