Efficacy of IVS Midazolam when interacting with cannabis

• Research type

  Research Study

• Full title

  The efficacy of intravenous Midazolam in the treatment of regular cannabis users requiring surgical exodontia

• IRAS ID

  201755

• Contact name

  Omesh Modgill

• Contact email

  omesh.modgill@nhs.net

• Sponsor organisation

  The R&D Office Kings College Hospital NHS Foundation Trust

• Duration of Study in the UK

  0 years, 6 months, 1 days

• Research summary

  This study aims to establish the extent to which cannabis use affects the efficacy of the intravenous sedative Midazolam in patients undergoing treatment under intravenous sedation. Participant selection criteria is as follows :
  • Male
  • Adult – over the age of 18
  • Fit and healthy with no medical conditions – ASA I
  • Regular cannabis use (at least once weekly) – in any form except synthetic cannabis
  • No use of any other recreational drugs
  • No history of dental treatment under intravenous sedation
  • Attending for surgical extraction of a lower wisdom tooth
  This group will be compared with a control group who also meet the above criteria but who do not have any history of cannabis use.

  We aim to establish if there is a difference in patient experience between the two groups.
  Prior to attending for treatment all patients will be given a Modified Dental Anxiety Score survey to provide baseline information regarding their anxiety. One week after the procedure is carried patients will be contacted and asked to complete a post-operative survey regarding their experience under intravenous sedation.

  The operator experience will also be assessed using retrospective evaluation of ‘difficulty’ scoring which is completed as part of routine documentation.

  The findings of both surveys will be compiled to establish:
  • If the experience of cannabis users varies significantly from those who do not use cannabis
  • If cannabis users are significantly more difficult to manage under intravenous sedation

• REC name

  London - South East Research Ethics Committee

• REC reference

  16/LO/1016

• Date of REC Opinion

  21 Jun 2016

• REC opinion

  Unfavourable Opinion