Conscious Sedation
Conditions
Brief summary
The general objective of the study is to compare the efficacy of administering midazolam orally as syrup versus nasally with nasal atomizer. The specific objectives are to measure: 1) acceptability of the medication, 2) effect on behavior, 3) time of onset, 4) maximum working time.
Detailed description
* Prospective, parallel design * Study and control group: 100 healthy children (ASA 1), ages: 2-6 years, uncooperative (Frankl 1-2), that needs at least two similar dental treatments. Exclusion criteria: enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge. * Randomization: At the first appointment the subjects will assigned randomly to receive oral midazolam or nasal midazolam; * Sedation: oral midazolam dose is 0.5mg/kg. Nasal midazolam dose is 0.2mg/kg. During treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. * Acceptability of the medication: compliance in taking the medication will be assessed and recorded as: willingly, coaxed, forced, or failed (not administered). * Behavior during dental treatment: Houpt scale measures behavior by rating sleep, movement, crying and overall behavior. The degree of alertness, movement and crying will be assessed before, during (every 5 min) and after the operative procedure. The rating will be done by one observer blind to the route of administration. This blind observer will also monitor the pulse and oxygen saturation.
Interventions
DRUGoral midazolam
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
DRUGnasal midazolam
administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy children (ASA 1), uncooperative (Frankl 1-210), that needs at least two similar dental treatments.
Exclusion criteria
* enlarged tonsils (Brodsky's grading scale11 +3 = 50-75% airway obstruction, and +4 = \>75% airway obstruction), upper respiratory tract infection or nasal discharge.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Compliant With Oral or Nasal Midazolam Administration | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Behavior During Dental Treatment | 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 |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Oral Sedation 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. | 30 |
| Nasal Sedation 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 2 |
| Overall Study | low cooperation, referral to treatment under general anesthesia | 6 | 1 |
Baseline characteristics
| Characteristic | Nasal Sedation | Total | Oral Sedation |
|---|---|---|---|
| Age, Continuous | 4.46 years STANDARD_DEVIATION 1.25 | 4.36 years STANDARD_DEVIATION 1.32 | 4.25 years STANDARD_DEVIATION 1.39 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Israel | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Male | 16 Participants | 31 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 33 |
| other Total, other adverse events | 0 / 37 | 0 / 33 |
| serious Total, serious adverse events | 0 / 37 | 0 / 33 |
Outcome results
Primary
Number of Participants Compliant With Oral or Nasal Midazolam Administration
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).
Time frame: the compliance in taking the medication will be assessed at the time of administration and recorded immediately.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Oral Sedation | Number of Participants Compliant With Oral or Nasal Midazolam Administration | willingly | 11 Participants |
| Oral Sedation | Number of Participants Compliant With Oral or Nasal Midazolam Administration | coaxed | 14 Participants |
| Oral Sedation | Number of Participants Compliant With Oral or Nasal Midazolam Administration | forced | 5 Participants |
| Nasal Sedation | Number of Participants Compliant With Oral or Nasal Midazolam Administration | willingly | 4 Participants |
| Nasal Sedation | Number of Participants Compliant With Oral or Nasal Midazolam Administration | coaxed | 18 Participants |
| Nasal Sedation | Number of Participants Compliant With Oral or Nasal Midazolam Administration | forced | 8 Participants |
Secondary
Behavior During Dental Treatment
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
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Oral Sedation | Behavior During Dental Treatment | 5.17 score on a scale | Standard Deviation 0.79 |
| Nasal Sedation | Behavior During Dental Treatment | 4.80 score on a scale | Standard Deviation 0.8 |