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Dronabinol Is Not a Game Changer in Pediatric Palliative Care: Results from a Retrospective Study
Holger Hauch1,2, Annika Lisakowski2,3, Julia Wager1,2,3
1Pediatric Palliative Care Centre, Children's and Adolescents' Hospital Datteln, 45711 Datteln, Germany.
Insights
Dronabinol (DRB) showed limited efficacy for symptoms like spasticity and restlessness in pediatric inpatients with life-limiting conditions. Severe side effects, including respiratory depression, were observed, necessitating cautious use.
Area of Science:
- Pediatric palliative care
- Neuropharmacology
- Cannabinoid therapeutics
Background:
- Patients with life-limiting conditions (LLCs) experience symptoms such as restlessness, spasticity, pain, and seizures.
- Dronabinol (DRB), a cannabinoid, may offer relief, but data in pediatric inpatients with LLCs are scarce.
- This study aimed to evaluate the efficacy and safety of DRB in this population.
Purpose of the Study:
- To assess the effectiveness of Dronabinol (DRB) in managing symptoms in pediatric inpatients with life-limiting conditions (LLCs).
- To evaluate the safety profile of Dronabinol (DRB) in this vulnerable patient group.
- To compare DRB efficacy when initiated during hospitalization versus prior use.
Main Methods:
- Retrospective analysis of inpatient data from 2011 to 2021.
- Inclusion of 63 pediatric patients with LLCs treated with DRB, predominantly those with neurological diseases.
- Comparison of patients initiating DRB during the study period versus those already on DRB upon admission.
Main Results:
- Subjective improvements in spasticity (47.6%) and restlessness (27%) were reported, but objective measures showed no reduction in seizures or restlessness.
- Effective DRB doses differed between newly initiated patients (0.21 mg/kg/BW/day) and those with pre-existing treatment (0.48 mg/kg/BW/day).
- Severe side effects, including respiratory depression, occurred in three patients, with fatigue and behavioral issues also reported.
Conclusions:
- Subjective benefits of Dronabinol (DRB) in pediatric inpatients with LLCs were not consistently supported by objective data.
- The potential for severe adverse events necessitates careful monitoring and clear indications for DRB use.
- Initiation of DRB should occur in a controlled, monitored setting for pediatric patients with life-limiting conditions.
Background/Objectives:
Patients with life-limiting conditions (LLCs) often suffer from restlessness, spasticity, pain, and seizures. Dronabinol (DRB) may have a relieving effect; however, data on the effectiveness of DRB in children with LLCs are limited to outpatients. The aim of this study was to assess the efficacy and safety of DRB.
Methods:
Retrospective analysis of inpatients.
Results:
From 2011 to 2021, 1219 patients were admitted. Of these, 63 patients (63.5% male, age: 10.4 (SD = 6.3) years) were treated with DRB; 96.8% had a neurological disease, and 26 patients were started on DRB (group A), while 37 were admitted with existing DRB (group B). The effective doses were 0.21 (SD = 0.11) in group A and 0.48 (SD = 0.5) mg/kg/BW/day in group B (p = 0.01). Subjective response rates to DRB in both groups (good/moderate effect) were 9.5%/38.1% for spasticity and 1.6%/25.4% for restlessness. However, no reduction in seizures, restlessness, or demand medication was observed in 24 h protocols when patients started DRB in group A. Three patients experienced severe side effects (e.g., respiratory depression). Other side effects included fatigue (22.2%) and behavioral problems (14.3%).
Conclusions:
Subjective positive effects could not be confirmed by more objective data. Side effects can be severe. Thus, DRB should be started in a well-monitored setting and only with clear indications.
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