Outcomes of a controlled trial with visiting therapy dog teams on pain in adults in an emergency department.

CONTEXT: Pain is a primary reason individuals attend an Emergency Department (ED), and its management is a concern. OBJECTIVES: Change in symptoms and physiologic variables at 3 time points pre-post a ten-minute St. John Ambulance therapy dog team visit compared to no visit in ED patients who experienced pain. DESIGN, SETTING AND PARTICIPANTS: Using a controlled clinical trial design, pain, anxiety, depression and well-being were measured with the Edmonton Symptom Assessment System (revised version) (ESAS-r) 11-point rating scales before, immediately after, and 20 minutes post- therapy dog team visit with Royal University Hospital ED patients participating in the study (n = 97). Blood pressure and heart rate were recorded at the time points. Control data was gathered twice (30 minutes apart) for comparison (n = 101). There were no group differences in age, gender or ethnicity among the control and intervention groups (respectively mean age 59.5/57.2, ethnicity 77.2% Caucasian/87.6%, female 43.6% /39.2%, male 56.4%/60.8%,). INTERVENTION: 10 minute therapy dog team visit in addition to usual care. MAIN OUTCOME MEASURES: Change in reported pain from pre and post therapy dog team visit and comparison with a control group. RESULTS: A two-way ANOVA was conducted to compare group effects. Significant pre- post-intervention differences were noted in pain for the intervention (mean changeint. = -0.9, SD = 2.05, p = .004, 95% confidence interval [CI] = [0.42, 1.32], ηp2 = 04) but not the control group. Anxiety (mean changeint. = -1.13, SD = 2.80, p = .005, 95% CI = [0.56, 1.64], ηp2 = .04), depression (mean changeint. = -0.72, SD = 1.71, p = .002, 95% CI = [0.39, 1.11], ηp2 = .047), and well-being ratings (mean changeint. = -0.87, SD = 1.84, p < .001, 95% CI = [0.49, 1.25], ηp2 = .07) similarly improved for the intervention group only. There were no pre-post intervention differences in blood pressure or heart rate for either group. Strong responders to the intervention (i.e. >50% reduction) were observed for pain (43%), anxiety (48%), depression (46%), and well-being (41%). CONCLUSIONS: Clinically significant changes in pain as well as significant changes in anxiety, depression and well-being were observed in the therapy dog intervention compared to control. The findings of this novel study contribute important knowledge towards the potential value of ED therapy dogs to affect patients' experience of pain, and related measures of anxiety, depression and well-being. TRIAL REGISTRATION: This controlled clinical trial is registered with ClinicalTrials.gov, registration number NCT04727749.

Dosage Related Efficacy and Tolerability of Cannabidiol in Children With Treatment-Resistant Epileptic Encephalopathy: Preliminary Results of the CARE-E Study.

Purpose: There is uncertainty regarding the appropriate dose of Cannabidiol (CBD) for childhood epilepsy. We present the preliminary data of seven participants from the Cannabidiol in Children with Refractory Epileptic Encephalopathy (CARE-E) study. Methods: The study is an open-label, prospective, dose-escalation trial. Participants received escalating doses of a Cannabis Herbal Extract (CHE) preparation of 1:20 Δ9-tetrahydrocannabinol (THC): CBD up to 10-12 mg CBD/kg/day. Seizure frequency was monitored in daily logs, participants underwent regular electroencephalograms, and parents filled out modified Quality of Life in Childhood Epilepsy (QOLCE) and Side Effect rating scale questionnaires. Steady-state trough levels (Css, Min) of selected cannabinoids were quantified. Results: All seven participants tolerated the CHE up to 10-12 mg CBD/kg/day and had improvements in seizure frequency and QOLCE scores. CSS, Min plasma levels for CBD, THC, and cannabichromene (CBC) showed dose-independent pharmacokinetics in all but one participant. CSS, Min CBD levels associated with a >50% reduction in seizures and seizure freedom were lower than those reported previously with purified CBD. In most patients, CSS, Min levels of THC remained lower than what would be expected to cause intoxication. Conclusion: The preliminary data suggest an initial CBD target dose of 5-6 mg/kg/day when a 1:20 THC:CBD CHE is used. Possible non-linear pharmacokinetics of CBD and CBC needs investigation. The reduction in seizure frequency seen suggests improved seizure control when a whole plant CHE is used. Plasma THC levels suggest a low risk of THC intoxication when a 1:20 THC:CBD CHE is used in doses up to 12 mg/kg CBD/kg/day.