Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04688346
Status:
COMPLETED
Last Update Posted:
2021-05-13
First Post:
2020-11-02
Brief Title:
Cardiovascular Effects of Racemic Epinephrine Pellets
Sponsor:
University of Washington
Organization:
University of Washington
Study Overview
Official Title:
Cardiovascular Effects of Racemic Epinephrine Pellets Used in Pediatric Restorative Dentistry Under General Anesthesia
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary aim of this study was to determine if topical racemic epinephrine pellets affect heart rate HR systolic blood pressure SBP diastolic blood pressure DBP or mean arterial pressure MAP in children receiving dental care under general anesthesia GA Thirteen patients requiring prefabricated zirconia crowns on both primary maxillary first molars were recruited into a split-mouth randomized controlled pilot study Patients received a continuous infusion of propofol and remifentanil with inhaled nitrous oxideoxygen After patient randomization and tooth preparation either saline pellets control or racemic epinephrine pellets treatment were applied directly to gingival tissue Vital sign measurements were recorded for 5 minutes The procedure was repeated with either control or treatment on the contralateral side
Detailed Description:
Dental caries is the most common chronic disease of childhood 3-6 of US children experience early childhood caries a condition that may necessitate restorative dental treatment Prefabricated crowns are the treatment of choice for children with rampant caries involving large or multiple surface lesions or developmental defects In such situations crowns reinforce the tooth and provide increased durability and longevity over intracoronal restorations such as fillings They also reduce the chance that the tooth will experience recurrent decay
In routine clinical practice preformed metal crowns also known as stainless steel crowns SSC are frequently indicated due to their extreme durability relatively low cost and minimal technique sensitivity Stainless steel crowns SSC are no longer the only standard of care in restoring primary teeth Although SSCs are highly effective esthetics can be a concern for parents Prefabricated zirconia crowns provide an esthetic solution Zirconia is a crystalline dioxide of zirconium that has mechanical properties similar to those of metals while its color is similar to that of teeth According to a recent randomized controlled trial both SSC and zirconia crowns proved to be an excellent choice for molar teeth full coverage restorations However zirconia crowns performed better from the standpoint of esthetics gum tissue response and plaque retention Abdulhadi Bashaer S Abdullah Medhat M et al Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth Journal of pediatric dentistry 2017 Vol 5 issue 1 21-27
Both Stainless steel crown and zirconia crown preparations include removing caries followed by reducing the height of the tooth by 15 mm reducing the sides of the tooth to make the pre-fabricated crown fit on the tooth The SSC preparation requires subgingival reduction 1-2 mm below the gumline on anterior and posterior surfaces not medial and lateral The only additional preparation step that zirconia crown preparation involves is medial and lateral reduction of the tooth therefore there is little additional time that is needed for preparation of the crown since the only difference is the depth of the side reduction and preparing it circumferentially In addition the Primary Investigator PI is the provider who will be treating all patients The PI is an experienced pediatric dentist and has been providing both types of crowns to patients under general anesthesia every week for many years
The average time for a dental procedure under general anesthesia is between 1-3 hours Factors that increase time include extent of disease number of fillingscrowns placed and pediatric dentists experience
The pediatric dentist that will be doing the surgery on all patients has been practicing for many years and has prepared thousands of SSC and zirconia crowns Therefore it is not anticipated that it will require additional time to prepare the zirconia crowns versus stainless steel crowns
Vital signs BP and HR will be monitored for 4 minutestooth 5-8 minutes total See attached chart showing the difference During this time the patient will be continuously anesthetized and under close observation by the attending anesthesiologist This constitutes a minimal risk to a childs health
According to studies epinephrine half-life is about two minutes and once the epinephrine pellet is removed concentrations will drop by 9375 over 4 half-lives which is about 8 minutes Therefore if there is any effect on blood pressure it will show immediately and will go back to normal within the time frame that we are recording data The procedure will be stopped if the blood pressure is at a harmful range to patient
All children will have both of their maxillary primary first molars B I prepared for prefabricated Zirconia crowns Teeth that require pulpotomy or pulpectomy treatment will be excluded from the study
In the control group hemostasis will be achieved by using two pellets soaked with 09 sodium chloride physiological saline In the intervention group hemostasis will be achieved by using two racemic epinephrine HCl pellets HemeRX Racellet 3 Sprig Oral Health Technologies Inc Loomis CA Racellet 3 contains an average of 055 mg 042 to 068 mgpellet of racemic epinephrine hydrochloride per pellet
A standard general anesthesia protocol will be used during the study All monitoring equipment will be applied at this time for the measurement of vital signs throughout the anesthesia Vital signs will include respiratory rate oxygen-saturated hemoglobin percentage heart rate HR in beats per minute bpm and cardiac rhythm which will be continuously recorded from a 3-lead electrocardiogram ECG The systolic blood pressures SBP and diastolic blood pressures DBP will be measured in millimeters of mercury mmHg via ankle artery cuff connected to monitors
Investigators will use a randomization software before the enrollment of the first subject to randomly determine if the right or the left side of the mouth will be the intervention Once consent is obtained randomization software will be used again to determine whether the patient will be given control or intervention treatment first Once patients are under anesthesia and after other dental treatments are completed the maxillary first primary molars B I will be prepared for Zirconia crowns The crowns will be prepared independently One tooth will be prepared first the pre-fabricated crown will be tried on to make sure the fit is correct Next either intervention or control pellets will be placed around the gumline of the tooth and removed after one minute The vital signs will continue to be recorded for the next 4 minutes meanwhile he crown is being cemented on the tooth Once that is done the operator will move to the other tooth and repeat the same steps
The process of preparing the tooth for a Zirconia crown requires a circumferential subgingival preparation Tissue irritation and bleeding is inherent in this process Once the crown is ready to be permanently cemented hemostasis becomes very important In both the control and intervention group of teeth two pellets will be applied directly around the gingival tissue of the prepared tooth and held for one minute with direct pressure and then removed based on the manufacturers recommendation The time of application will be recorded The adequacy of hemostasis will be determined subjectively by the attending dentist and recorded as adequate or inadequate at 1 2 3 4 and 5 minutes after placement Adequate hemostasis is defined as gingival tissue being dry and hemorrhage-free Inadequate hemostasis is defined as inability to keep the gingival tissue dry and without hemorrhage If hemostasis is not achieved after four minutes of managing a subject during the study intervention saline or epinephrine pellets to which a tooth has been randomized we will revert to the standard of care in order to stop the bleeding Lidocaine will not be administered as a primary local anesthetic nor would it be used during our study Only epinephrine pellets and saline pellets will be used in the study for achieving hemostasis
Cardiovascular outcomes of patients systolic blood pressure SBP diastolic blood pressure DBP and heart rate HR will be collected by the graduate researcher during the procedure The researcher will record the blood pressureHR before placement of pellets immediately after placement and at 1 2 3 4 5 minutes after placement The pellets will stay on the tissue for 1 minute only and then removed The researcher will also record hemostasis efficacy as per dental surgeon as either adequate or inadequate during the procedure
In addition to the above measurements cardiac rhythms will be assessed continuously via ECG and recording any arrhythmias Mean arterial pressure MAP the amount of time in surgery and anesthesia medications used for each patient will also be recorded All patients will be discharged on the same day after adequate recovery observation time
In routine clinical practice preformed metal crowns also known as stainless steel crowns SSC are frequently indicated due to their extreme durability relatively low cost and minimal technique sensitivity Stainless steel crowns SSC are no longer the only standard of care in restoring primary teeth Although SSCs are highly effective esthetics can be a concern for parents Prefabricated zirconia crowns provide an esthetic solution Zirconia is a crystalline dioxide of zirconium that has mechanical properties similar to those of metals while its color is similar to that of teeth According to a recent randomized controlled trial both SSC and zirconia crowns proved to be an excellent choice for molar teeth full coverage restorations However zirconia crowns performed better from the standpoint of esthetics gum tissue response and plaque retention Abdulhadi Bashaer S Abdullah Medhat M et al Clinical evaluation between zirconia crowns and stainless steel crowns in primary molars teeth Journal of pediatric dentistry 2017 Vol 5 issue 1 21-27
Both Stainless steel crown and zirconia crown preparations include removing caries followed by reducing the height of the tooth by 15 mm reducing the sides of the tooth to make the pre-fabricated crown fit on the tooth The SSC preparation requires subgingival reduction 1-2 mm below the gumline on anterior and posterior surfaces not medial and lateral The only additional preparation step that zirconia crown preparation involves is medial and lateral reduction of the tooth therefore there is little additional time that is needed for preparation of the crown since the only difference is the depth of the side reduction and preparing it circumferentially In addition the Primary Investigator PI is the provider who will be treating all patients The PI is an experienced pediatric dentist and has been providing both types of crowns to patients under general anesthesia every week for many years
The average time for a dental procedure under general anesthesia is between 1-3 hours Factors that increase time include extent of disease number of fillingscrowns placed and pediatric dentists experience
The pediatric dentist that will be doing the surgery on all patients has been practicing for many years and has prepared thousands of SSC and zirconia crowns Therefore it is not anticipated that it will require additional time to prepare the zirconia crowns versus stainless steel crowns
Vital signs BP and HR will be monitored for 4 minutestooth 5-8 minutes total See attached chart showing the difference During this time the patient will be continuously anesthetized and under close observation by the attending anesthesiologist This constitutes a minimal risk to a childs health
According to studies epinephrine half-life is about two minutes and once the epinephrine pellet is removed concentrations will drop by 9375 over 4 half-lives which is about 8 minutes Therefore if there is any effect on blood pressure it will show immediately and will go back to normal within the time frame that we are recording data The procedure will be stopped if the blood pressure is at a harmful range to patient
All children will have both of their maxillary primary first molars B I prepared for prefabricated Zirconia crowns Teeth that require pulpotomy or pulpectomy treatment will be excluded from the study
In the control group hemostasis will be achieved by using two pellets soaked with 09 sodium chloride physiological saline In the intervention group hemostasis will be achieved by using two racemic epinephrine HCl pellets HemeRX Racellet 3 Sprig Oral Health Technologies Inc Loomis CA Racellet 3 contains an average of 055 mg 042 to 068 mgpellet of racemic epinephrine hydrochloride per pellet
A standard general anesthesia protocol will be used during the study All monitoring equipment will be applied at this time for the measurement of vital signs throughout the anesthesia Vital signs will include respiratory rate oxygen-saturated hemoglobin percentage heart rate HR in beats per minute bpm and cardiac rhythm which will be continuously recorded from a 3-lead electrocardiogram ECG The systolic blood pressures SBP and diastolic blood pressures DBP will be measured in millimeters of mercury mmHg via ankle artery cuff connected to monitors
Investigators will use a randomization software before the enrollment of the first subject to randomly determine if the right or the left side of the mouth will be the intervention Once consent is obtained randomization software will be used again to determine whether the patient will be given control or intervention treatment first Once patients are under anesthesia and after other dental treatments are completed the maxillary first primary molars B I will be prepared for Zirconia crowns The crowns will be prepared independently One tooth will be prepared first the pre-fabricated crown will be tried on to make sure the fit is correct Next either intervention or control pellets will be placed around the gumline of the tooth and removed after one minute The vital signs will continue to be recorded for the next 4 minutes meanwhile he crown is being cemented on the tooth Once that is done the operator will move to the other tooth and repeat the same steps
The process of preparing the tooth for a Zirconia crown requires a circumferential subgingival preparation Tissue irritation and bleeding is inherent in this process Once the crown is ready to be permanently cemented hemostasis becomes very important In both the control and intervention group of teeth two pellets will be applied directly around the gingival tissue of the prepared tooth and held for one minute with direct pressure and then removed based on the manufacturers recommendation The time of application will be recorded The adequacy of hemostasis will be determined subjectively by the attending dentist and recorded as adequate or inadequate at 1 2 3 4 and 5 minutes after placement Adequate hemostasis is defined as gingival tissue being dry and hemorrhage-free Inadequate hemostasis is defined as inability to keep the gingival tissue dry and without hemorrhage If hemostasis is not achieved after four minutes of managing a subject during the study intervention saline or epinephrine pellets to which a tooth has been randomized we will revert to the standard of care in order to stop the bleeding Lidocaine will not be administered as a primary local anesthetic nor would it be used during our study Only epinephrine pellets and saline pellets will be used in the study for achieving hemostasis
Cardiovascular outcomes of patients systolic blood pressure SBP diastolic blood pressure DBP and heart rate HR will be collected by the graduate researcher during the procedure The researcher will record the blood pressureHR before placement of pellets immediately after placement and at 1 2 3 4 5 minutes after placement The pellets will stay on the tissue for 1 minute only and then removed The researcher will also record hemostasis efficacy as per dental surgeon as either adequate or inadequate during the procedure
In addition to the above measurements cardiac rhythms will be assessed continuously via ECG and recording any arrhythmias Mean arterial pressure MAP the amount of time in surgery and anesthesia medications used for each patient will also be recorded All patients will be discharged on the same day after adequate recovery observation time
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None