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Completed

NCT Number: NCT04500158

The Effect of Local Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

The purpose of this study is to compare patient responses during and after surgery when local anesthetic is used for dental treatment under general anesthesia (GA) and when it is not used.

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Key information

Conditions

Pain, Procedural Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

Local anesthesia is a widely used tool to ensure patient safety and comfort in the dental office. This is usually accomplished by administering a shot of numbing medicine (local anesthesia) in different parts of the mouth. Local anesthesia is an important tool used for care in the dental office however despite its standardized use in dental clinics use of local anesthetic is not standardized for use in dental cases under GA. In the literature there is some evidence suggesting that it has some marginal benefit for pain control short term post operatively and control of vital signs during surgery. Some evidence also suggests that due to its use there can be increase in post-operative lip chewing and cheek biting due to the numb sensation. Additionally, it has been seen that due to the numb sensation that children can be more irritable during when waking up after surgery.

The study section will have 60 participants of which one half will receive local anesthesia for restorative dental care under GA and the other half will receive conventional no anesthesia for restorative dental treatment under GA, based on random assignment (like the flip of a coin). There is an equal chance of being assigned to either group prior to the consented treatment. Before the surgery, a nurse will access the child's overall pain and comfort. The study team (faculty, anesthesiologist, and resident) will record the blood pressure, heart rate, and breathing duration throughout the procedure. After the child has completed the surgery a nurse will again access the child's overall pain and comfort. Lastly, parents will be contacted that evening of surgery by a member of the study team to check up on the child and will be asked some questions to access the child's comfort at home.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pediatric patients undergoing GA for dental restorative work at Virginia Commonwealth University Children's Hospital of Richmond Pavilion and Brook Road Centers

Exclusion criteria

  • Children with any sensory or behavioral issues
  • Patients requiring extractions or surgical procedures

Treatment and study plan

Lidocaine

Drug

2% Lidocaine with 1:100,000 epi

Primary outcomes

  1. Post Operative Pain

    Time frame: in the evening of the day of surgery, up to 10 hours

    The Parent's Postoperative Pain Measure ( abbreviated: PPPM) Scale consists of 15 questions with scores ranging from 0 to 15, with one point assigned to each question answered with a "Yes" and therefore higher scores indicating worse postoperative pain. A score of 6 or greater is considered clinically significant pain which was tallied for the primary outcome measure (i..e number of participants experiencing clinically significant postoperative pain).

Secondary outcomes

  1. Number of Teeth Treated

    Time frame: start of procedure to end of procedure, the intraoperative time frme

    Will report the mean and standard deviation of number of teeth treated

  2. Procedure Time

    Time frame: start of procedure to end of procedure, minutes

    Will report the mean and standard deviation of the procedure time

  3. PACU Time

    Time frame: time from after procedure to through time in the post-anesthesia care unit in minutes

    Will report the mean and standard deviation of time after the procedure to through time in the post-anesthesia care unit

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Official study title

The Effect of Local Anesthesia When Used in Dental Restorative Cases Under General Anesthesia on Control of Intraoperative Physiologic Parameters and Post Operative Comfort

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 5, 2020
Registry last updated
Sep 19, 2024

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.

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