Phase 3
N=90
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
Anesthesia
Bottom Line
View on ClinicalTrials.gov: NCT01844830 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. — 46; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05% (Drug); Placebo (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- St. Renatus, LLC
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. |
46; 16 | — |
| SECONDARY Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic.by Dosage Cohort. |
14; 7; 14; 5; 18; 4 | — |
| SECONDARY Number of Participants Who Completed the Study Dental Procedure Without Need for Rescue by Injection of Local Anesthetic. by Age Group (3-5, 6-11, and 12-17 Years Old, Inclusive). |
17; 8; 14; 6; 15; 2 | — |
| SECONDARY Incidence of Adverse Events (AEs) by Dosage Cohort |
12; 6; 22; 9; 15; 7 | — |
| SECONDARY Incidence of Adverse Events (AEs) by Age Group |
17; 7; 19; 11; 13; 4 | — |
| SECONDARY Results of Naris Examination (NE) - Patency and Ulcerations |
59; 30; 0; 0 | — |
| SECONDARY Maximum Change From Baseline in Heart Rate |
5.6; 6.9 | — |
| SECONDARY Maximum Change From Baseline in Systolic Blood Pressure |
5.4; 1.0 | — |
| SECONDARY Maximum Change From Baseline in Diastolic Blood Pressure |
8.3; 2.4 | — |
| SECONDARY Results of Naris Examination (NE) - Color |
52; 25; 6; 5; 1; 0 | — |
| SECONDARY Results of Naris Examination (NE) - Inflammation |
57; 29; 2; 1; 0; 0 | — |
| SECONDARY Results of Naris Examination (NE) - Bleeding |
57; 29; 2; 1; 0; 0 | — |
Summary
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
Eligibility Criteria
Inclusion Criteria
- Male or female 3-17 years of age inclusive.
- Need for an operative restorative dental procedure and requiring local anesthesia on a single vital maxillary primary tooth (#A to J) or permanent tooth (#4 to13), with no evidence of pulpal pathology.
- Normal lip, nose, eyelid, and cheek sensation.
- Accompanied and/or represented by a parent or guardian able to comprehend and sign the informed consent document.
- Subject able to understand and provide assent to an age-appropriate subject assent form (as defined by local practice or regulation).
- Patient or parent/guardian able to communicate with the investigator and comply with the requirements of the protocol.
- Patency of the naris on the same side as the tooth undergoing the Study Dental Procedure (the Study Treatment Tooth).
Exclusion Criteria
- Having received dental care requiring a local anesthetic within the 24 hours preceding study entry.
- History of allergy to or intolerance of tetracaine, benzyl alcohol, other ester local anesthetics, or para-aminobenzoic acid (as found in PABA-containing sunscreen).
- History of allergy or hypersensitivity to lidocaine, oxymetazoline, epinephrine, or sulfite preservatives.
- Use of a monoamine oxidase inhibitor within the 3 weeks preceding study entry.
- Nursing, pregnant, suspected of being pregnant, or trying to become pregnant. (Females of child-bearing potential will be required to undergo urine testing on the day of, but prior to, study drug administration to rule out pregnancy.)
- Inadequately controlled thyroid disease of any type.
- Having received any investigational drug (including Kovacaine Mist) and/or participation in any clinical trial within 30 days of study participation.
- Frequent nose bleeds (≥ 5 per month).
- History of congenital or idiopathic methemoglobinemia.
- Presence of an upper respiratory infection and/or fever defined as body temperature ≥100.4° (38°C) on the day of and prior to study drug administration.
Data sourced from ClinicalTrials.gov (NCT01844830). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.