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Trial · NCT01660893

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryCompletion of the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic (Yes/no).at 15 minutes with a 3 minute window
SecondaryIntraoral Soft-tissue Anesthesia (Yes/no)at 15 minutes with a 3 minute windowNumber of patients who reported no pain when incisive papilla and greater palatine foramen soft-tissue was tested with a probe
SecondaryNumber of Participants With Heart Rate Higher Than 125 Bpmat any time within 120 minutes following drug administration
SecondaryNumber of Participants With Heart Rate Lower Than 50 Bpmat any time within 120 minutes following drug administration
SecondaryNumber of Participants With an Increase From Baseline in Systolic Blood Pressure Greater Than or Equal to 25 mm Hg and to a Value Higher Than 160 mm Hgat any time within 120 minutes following drug administration
SecondaryNumber of Participants With a Decrease From Baseline in Systolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hgat any time within 120 minutes following drug administration
SecondaryNumber of Participants With an Increase From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Higher Than 90 mm Hgat any time within 120 minutes following drug administration
SecondaryNumber of Participants With a Decrease From Baseline in Diastolic Blood Pressure Greater Than or Equal to 15 mm Hg and to a Value Lower Than 90 mm Hgat any time within 120 minutes following drug administration
SecondaryAbsolute Maximum Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressurefrom baseline to 120 minutes following drug administration
SecondaryThe Profile Over Time of Heart Ratefrom baseline to 120 minutes following drug administration
SecondaryAlcohol Sniff Testadministered at approximately 24 hours after drug administrationThe change from screening in the the distance from the nose (in centimeters) that a patient is able to detect the smell of an alcohol swab.
SecondaryThe Profile Over Time of Systolic Blood Pressurefrom baseline to 120 minutes following drug administration
SecondaryThe Profile Over Time of Diastolic Blood Pressurefrom baseline to 120 minutes following drug administration
SecondaryAbsolute Maximum Change From Baseline in Heart Ratefrom baseline to 120 minutes following drug administration

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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