Evaluating use of inhaled dexmedetomidine for pain management in adult burn injury dressing changes

This is a pilot phase III randomised controlled crossover trial to evaluate the feasibility and safety of conducting a large randomized controlled trial to provide effective analgesia using nebulized dexmedetomidine as an adjunct to conventional therapy for procedural pain management in burns patients. In addition, to capture pilot data to inform estimates of analgesic effect associated with nebulized dexmedetomidine when added to the conventional therapy used for procedural pain management in burns patients. The drug, Dexmedetomidine, will be used for its registered purpose, sedation and analgesia, however this study will be investigating the use of an alternative method of administration (nebulisation) and will be compared with a placebo (0.9 % sodium chloride). In this study 20 patients who meet the inclusion criteria and none of the exclusion criteria will be recruited. Participants will be randomised to receive either nebulised Dexmedetomidine or Placebo (0.9% Sodium Chloride) on the first occasion followed by the alternate option on the second occasion. This is in addition to the routine analgesia and sedation prescribed by the treating clinician. There will be at least 24 hours between the first and second dressing occasion. A vibrating mesh nebulizer with mouthpiece and exhalation filter will be used for this study. Patients will inhale the nebulized drug through a mouthpiece and will be instructed in detail using a demonstration by the research assistant regarding the inhalation method through the nebulizer. Intervention- Dexmedetomidine 1 µg/kg will be instilled in the nebulizer chamber to make up to 3 mL of volume. Nebulization will be continued till there is no visible mist. The nebulized dose will be administered over approximately 1o minutes within 30 minutes prior to the commencement of the dressing change. Participants will be observed for adherence and acceptance of the nebulisation procedure using a 9-point Likert scale. And monitored for adverse events relating to the study intervention. Monitoring fidelity: A monitoring plan has been established for this study, including a Data Safety Monitoring Board. Protocol adherence will be easily monitored as this is a single site study and the study team will be directly involved in each case. The study will be conducted in accordance with ethical principles consistent with the Declaration of Helsinki, and all relevant national and local guidelines on the ethical conduct of research. The research team will include experienced research coordinators, intensive care specialists as all with GCP training and they will have oversight of all study required activities and protocol adherence. All data will be directly entered from the source into the electronic database. The data base has the capacity to run validity checks and logic queries to minimise errors. The study monitor will perform 100% source data verification (SDV) for the first patient recruited and 100% SDV on all patients for informed consent in accordance with the HREC approval, reportable adverse events as per protocol, clinical outcome or pain assessment, and protocol deviations.