A non-interventional, observational study in Germany to evaluate the effectiveness of reversal of local anesthesia and occurrence of adverse events in patients treated with OraVerse® in dental office (OraNIS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective, multicenter, open-label, non-controlled, non-interventional, observational study

Study drug and medical condition

• Name of medicine, other:
  OraVerse

Population studied

• Short description of the study population:
  Patients that were treated with OraVerse® for reversal of local soft-tissue anesthesia after routine dental treatment in dental office.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  445

Study design details

• Main study objective:
  The primary objectives were to investigate patients treated with OraVerse® after local anesthesia with an anesthetic containing epinephrine (adrenalin) as part of a routine dental procedure in terms of- Time to recovery of normal sensation in the lip/tongue.- Time to recovery of normal function (eating, drinking and speaking).
• Data analysis plan:
  Data collection: Dentists were to report on 3 to 4 patients treated with OraVerse® on a paper case report form (CRF).Safety data collection: AEs and serious AEs (SAEs) were collected by dentists at the follow-up interviews and recorded on (S)AE report forms.Data management, review, validation: Quality checks for source data verification were done on-site as well as by phone by the CRO. Quality control was done as described in the Data Management Plan (DMP). Data were subjected to plausibility checks and implausible data were corrected or excluded from analysis as described in the Data Validation Plan (DVP).Statistical considerations:Data management and statistical analysis were done with SAS, version 9.2.All study data were analyzed in an exploratory fashion by means of descriptivestatistics.