Conectar
by Karim S. Ladha, Jiwon Lee, Gabriella F. Mattina, Janneth Pazmino-Canizares, Duminda N. Wijeysundera, Fatemeh Gholamali Nezhad, Kaylyssa Philip, Vanessa K. Tassone, Fathima Adamsahib, Venkat Bhat, on behalf of the SMILE Study Investigators
BackgroundNitrous oxide has shown potentially as an efficacious intervention for treatment-resistant depression, yet there remains insufficient evidence pertaining to repeated administration of nitrous oxide over time and active placebo-controlled studies with optimal blinding. Thus, we aim to examine the feasibility and preliminary efficacy of a six-week follow up study examining the effects of a 4 week course of weekly administered nitrous oxide as compared to the active placebo, midazolam.
MethodsIn this randomized, active placebo-controlled, pilot trial, 40 participants with treatment-resistant depression will receive either inhaled nitrous oxide (1 hour at 50% concentration) plus intravenous saline (100mL) or inhaled oxygen (1 hour at 50% concentration) plus intravenous midazolam (0.02 mg/kg in 100mL, up to 2mg) once per week, for 4 consecutive weeks. Participants will be followed up for 6 weeks starting from the first treatment visit. Primary feasibility outcomes include recruitment rate, withdrawal rate, adherence, missing data, and adverse events. The primary exploratory clinical outcome is change in Montgomery-Åsberg Depression Rating Scale (MADRS) score at day 42 of the study. Other exploratory clinical outcomes include remission (defined as MADRS score Discussion
This pilot study will provide valuable information regarding the feasibility and preliminary efficacy of repeated nitrous oxide administration over time for treatment-resistant depression. If feasible, this study will inform the design of a future definitive trial of nitrous oxide as an efficacious and fast-acting treatment for treatment-resistant depression.
Trial registrationClinicalTrials.gov NCT04957368. Registered on July 12, 2021.
Increased use of opioids and their associated harms have raised concerns around prescription opioid use for pain management following surgery. We examined trends and patterns of opioid prescribing following elective orthopaedic surgery.
Population-based study.
Ontario, Canada.
Ontario residents aged 66+ years who had elective orthopaedic surgery from April 2004 to March 2018.
Postoperative opioid use (short term: within 90 days of surgery, prolonged: within 180 days and chronic: within 1 year), specific opioids prescribed, average duration (days) and amount (morphine milligram equivalents) of the initial prescription by year of surgery.
We included 464 460 elective orthopaedic surgeries in 2004/2005–2017/2018: 80% of patients used opioids within 1 year of surgery—25.1% were chronic users. There was an 8% increase in opioid use within 1 year of surgery, from 75.1% in 2004/2005 to 80.9% in 2017/2018: a 29% increase in short-term use and a decline in prolonged (9%) and chronic (22%) use. After 2014/2015, prescribed opioid amounts initially declined sharply, while the duration of the initial prescription increased substantially. Across categories of use, there was a steady decline in coprescription of benzodiazepines and opioids.
Most patients filled opioid prescriptions after surgery, and many continued filling prescriptions after 3 months. During a period of general increase in awareness of opioid harms and dissemination of guidelines/policies aimed at opioid prescribing for chronic pain, we found changes in prescribing practices following elective orthopaedic surgery. Findings illustrate the potential impact of guidelines/policies on shaping prescription patterns in the surgical population, even in the absence of specific guidelines for surgical prescribing.
FreshRSS 