Study register · detailOffene retrospektive Studie · Palliative Care · 2016
Effective treatment of spasticity using dronabinol in pediatric palliative care.
Kuhlen et al.·European Journal of Paediatric NeurologyImpact 2.2
Clear benefitGRADEVery low48 citations
Samplen = 16 Pat.
DurationMedian 181 days
EndpointSpasticity
Blindingn.a.
DesignOffene retrospektive Studie
Cannabinoidthc
Routeoral
”Key finding
Dronabinol reduced or eliminated refractory spasticity in 12 of 16 pediatric palliative patients.
Summary
Pediatric palliative care, n=16 children/adolescents with complex neurological diseases and refractory spasticity; dronabinol (2,5% THC oil), median 0,33 mg/kg/d; 12/16 patients benefited (resolution of spasticity or marked improvement); severe or persistent adverse effects did not occur even in young children and long-term treatment (181 days median).
P
PopulationChildren, adolescents and young adults with complex neurological diseases and refractory spasticity in pediatric palliative care, n=16, age 1,3–26,6 years
OutcomeIn 12 of 16 patients resolution or marked improvement of spasticity; 2 patients without benefit, 2 not assessable; rare side effects (vomiting, agitation each in 1 patient)
Confidence in the evidence
Very lowLowModerateHigh
Very low
The lowest GRADE level, the effect estimate remains uncertain.
Downgraded for
Imprecision
Quality profile
Sample size★★★★★
Blinding—
Effect sizeClear benefit
Citations / year★★★★★
Authors
Kuhlen M, Hoell JI, Gagnon G, Balzer S, Oommen PT, Borkhardt A, Janßen G.
<h4>Background</h4>Cannabis extracts have a wide therapeutic potential but in many countries they have not been approved for treatment in children so far.<h4>Objective</h4>We conducted an open, uncontrolled, retrospective study on the administration of dronabinol to determine the value, efficacy, and safety of cannabis-based medicines in the treatment of refractory spasticity in pediatric palliative care.<h4>Design and participants</h4>Sixteen children, adolescents and young adults having complex neurological conditions with spasticity (aged 1.3-26.6 years, median 12.7 years) were treated with dronabinol by our specialized pediatric palliative care team between 01.12.2010 and 30.04.2015 in a home-care setting. Therapeutic efficacy and side effects were closely monitored.<h4>Results</h4>Drops of the 2.5% oily tetrahydrocannabinol solution (dronabinol) were administered. A promising therapeutic effect was seen, mostly due to abolishment or marked improvement of severe, treatment resistant spasticity (n = 12). In two cases the effect could not be determined, two patients did not benefit. The median duration of treatment was 181 days (range 23-1429 days). Dosages to obtain a therapeutic effect varied from 0.08 to 1.0 mg/kg/d with a median of 0.33 mg/kg/d in patients with a documented therapeutic effect. When administered as an escalating dosage scheme, side effects were rare and only consisted in vomiting and restlessness (one patient each). No serious and enduring side effects occurred even in young children and/or over a longer period of time.<h4>Conclusions</h4>In the majority of pediatric palliative patients the treatment with dronabinol showed promising effects in treatment resistant spasticity.