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OpenTrials
Completed

NCT Number: NCT02735018

Comparing Cardiovascular Effects of 1:100,000 and 1:200,000 Epinephrine Solutions

The study aim to evaluate systemic response of patients when 2 different concentrations of Epinephrine are injected during inferior alveolar nerve block for wisdom teeth extraction.

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Key information

Age range

13 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Class I patients according to the American Society of Anesthesiology (ASA),
  • Indication for third molars extraction,
  • Similar degree of complexity, according to the classification of Pell and Gregory.

Exclusion criteria

  • Patients with systemic conditions,
  • Patients with known allergy to any component of the anesthetic solution.

Treatment and study plan

Epinephrine 1:100,000

Drug

Inferior alveolar nerve block with Epinephrine 1:100.000

Epinephrine 1:200,000

Drug

Inferior alveolar nerve block with Epinephrine 1:200.000

Primary outcomes

  1. Heart rate

    Time frame: 20 minutes

  2. Blood pressure

    Time frame: 20 minutes

  3. Arterial oxygen saturation, measured with a pulse oximeter device

    Time frame: 20 minutes

  4. Bleeding, evaluated by the surgeon as either: 1) normal or 2) excessive

    Time frame: 20 minutes

  5. Pain, evaluated using a visual analogue scale

    Time frame: After procedure, about 1 hour

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Official study title

Randomized Double-blind Clinical Trial Comparing the Cardiovascular Effects of Local Anesthesia Solutions Containing 1:100,000 and 1:200,000 of Epinephrine Concentrations

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 12, 2016
Registry last updated
Apr 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.