Trial Outcomes & Findings for Nasal Versus Oral Midazolam Sedation in Routine Pediatric Dental Care (NCT NCT02679781)
NCT ID: NCT02679781
Last Updated: 2022-01-14
Results Overview
the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
70 participants
Primary outcome timeframe
the compliance in taking the medication will be assessed at the time of administration and recorded immediately.
Results posted on
2022-01-14
Participant Flow
Participant milestones
| Measure |
Oral Sedation
administration of 0.5mg/kg oral midazolam.
|
Nasal Sedation
administration of 0.2mg/kg nasal midazolam.
|
|---|---|---|
|
Overall Study
STARTED
|
37
|
33
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
Reasons for withdrawal
| Measure |
Oral Sedation
administration of 0.5mg/kg oral midazolam.
|
Nasal Sedation
administration of 0.2mg/kg nasal midazolam.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
|
Overall Study
low cooperation, referral to treatment under general anesthesia
|
6
|
1
|
Baseline Characteristics
Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
Baseline characteristics by cohort
| Measure |
Oral Sedation
n=30 Participants
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
|
Nasal Sedation
n=30 Participants
administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
4.25 years
STANDARD_DEVIATION 1.39 • n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
4.46 years
STANDARD_DEVIATION 1.25 • n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
4.36 years
STANDARD_DEVIATION 1.32 • n=60 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
|
Sex: Female, Male
Female
|
15 Participants
n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
14 Participants
n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
29 Participants
n=60 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
|
Sex: Female, Male
Male
|
15 Participants
n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
16 Participants
n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
31 Participants
n=60 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Israel
|
30 participants
n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
30 participants
n=30 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
60 participants
n=60 Participants • Drop out- 10 were excluded from the analysis: seven due to lack of cooperation and referral to treatment under general anesthesia, six of whom received oral midazolam. Three participants did not attend the second treatment (one of them received oral midazolam).
|
PRIMARY outcome
Timeframe: the compliance in taking the medication will be assessed at the time of administration and recorded immediately.the compliance in taking the medication will be assessed at the time of administration by one of the investigators and recorded immediately as: willingly, coaxed, forced, or failed (not administered).
Outcome measures
| Measure |
Oral Sedation
n=30 Participants
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
|
Nasal Sedation
n=30 Participants
administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
|
|---|---|---|
|
Number of Participants Compliant With Oral or Nasal Midazolam Administration
willingly
|
11 Participants
|
4 Participants
|
|
Number of Participants Compliant With Oral or Nasal Midazolam Administration
coaxed
|
14 Participants
|
18 Participants
|
|
Number of Participants Compliant With Oral or Nasal Midazolam Administration
forced
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: the effect of oral or nasal midazolam on behaviour will be assessed during dental treatment.The length of each treatment is estimated as 30-45 minutes.the effect of oral or nasal midazolam on behaviour will be assessed by blind observer using Houpt scale. Houpt scale measures behavior by rating overall behavior. the scale is 1 to 6, higher score mean a better behavior. 1. = Aborted, no treatment rendered. 2. = Poor, treatment interrupted, only partial treatment was completed 3= Fair, treatment interrupted but eventually completed 4= Good, difficult but all treatment was performed 5= Very good, some limited crying or movement 6= Excellent, no crying or movement
Outcome measures
| Measure |
Oral Sedation
n=30 Participants
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
oral midazolam: administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
|
Nasal Sedation
n=30 Participants
administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
nasal midazolam: administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
|
|---|---|---|
|
Behavior During Dental Treatment
|
5.17 score on a scale
Standard Deviation 0.79
|
4.80 score on a scale
Standard Deviation 0.80
|
Adverse Events
Oral Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Nasal Sedation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Avia Fux-Noy
Hadassah School of Dental Medicine, P.O.Box 12272
Phone: +97226776135
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place