Ignite Creation Date:
2024-05-06 @ 11:38 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03562481
Status:
COMPLETED
Last Update Posted:
2020-06-25
First Post:
2018-06-05
Brief Title:
Clinical Trial Comparing Effectiveness of Buffered Versus Unbuffered Local Anesthetic in Children Ages 10-12 Years
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Pilot Study Comparison of Buffered 1 vs Unbuffered 2 Lidocaine in Pediatric Subjects Clinical Outcomes
Status:
COMPLETED
Status Verified Date:
2020-02
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:
Local anesthesia is an integral part of clinical pediatric dental practice but it has challenges It can be uncomfortable for children and the risk of adverse events limits how much is used Some evidence suggests benefits of buffering local anesthetics including equal effect with less pain on injection These findings have not been replicated and validated among pediatric populations creating a gap in the knowledge base To address this knowledge gap and contribute to the evidence base on safety and efficacy of local anesthesia in pediatric dentistry this investigation proposes to compare the anesthetic effects of buffered 1 lidocaine with those of unbuffered 2 among children
The specific aims of this investigation are to determine differences between buffered 1 and unbuffered 2 lidocaine both with 1100000 epinephrine used for inferior alveolar nerve block IAN anesthesia in the following domains
1 Pain experience on injection time to onset following the administration and time to recovery subjective
2 Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia objective
Null Hypotheses
1 No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1 Lidocaine with 1100000 epinephrine as compared to unbuffered 2 Lidocaine with 1100000 epinephrine
2 No differences exist in peak blood lidocaine levels pain on injection time to lip numbness and duration of anesthesia between the two drug formulations
Randomized subjects will be injected orally for bottom jaw anesthesia with 3cc of buffered 1 lidocaine 30mg 1100000 epinephrine or 3cc unbuffered of 2 lidocaine 60mg 1100000 epinephrine The injectable volume of the buffered formulation will include 03cc of 84 sodium bicarbonate
One faculty member in the Department of Pediatric Dentistry at the University of North Carolina UNC School of Dentistry will administer the drugs in the Pediatric Dentistry clinic The same clinician will administer injection to the same subjects at both visits Clinicians and subjects will not know which drug formulation is given at which appointment
A clinician will measure the level of discomfort on injection how long it takes for the lip to be numb how long it takes for the first molar tooth in that area to be numb how long it takes the local anesthetic to wear off and how much of the anesthetic is in the blood
The specific aims of this investigation are to determine differences between buffered 1 and unbuffered 2 lidocaine both with 1100000 epinephrine used for inferior alveolar nerve block IAN anesthesia in the following domains
1 Pain experience on injection time to onset following the administration and time to recovery subjective
2 Blood lidocaine levels 15 minutes following the administration and duration of pulpal anesthesia objective
Null Hypotheses
1 No difference exists in anesthetic effectiveness for pulpal anesthesia after intraoral IAN block between buffered 1 Lidocaine with 1100000 epinephrine as compared to unbuffered 2 Lidocaine with 1100000 epinephrine
2 No differences exist in peak blood lidocaine levels pain on injection time to lip numbness and duration of anesthesia between the two drug formulations
Randomized subjects will be injected orally for bottom jaw anesthesia with 3cc of buffered 1 lidocaine 30mg 1100000 epinephrine or 3cc unbuffered of 2 lidocaine 60mg 1100000 epinephrine The injectable volume of the buffered formulation will include 03cc of 84 sodium bicarbonate
One faculty member in the Department of Pediatric Dentistry at the University of North Carolina UNC School of Dentistry will administer the drugs in the Pediatric Dentistry clinic The same clinician will administer injection to the same subjects at both visits Clinicians and subjects will not know which drug formulation is given at which appointment
A clinician will measure the level of discomfort on injection how long it takes for the lip to be numb how long it takes for the first molar tooth in that area to be numb how long it takes the local anesthetic to wear off and how much of the anesthetic is in the blood
Detailed Description:
None
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?:
True
Is an FDA AA801 Violation?:
None