An interventional study of oral midazolam and nasal midazolam in Conscious Sedation, sponsored by Hadassah Medical Organization. Completed at 1 site in Israel. Open to participants aged 2 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-01-14.
Sponsored by Hadassah Medical Organization · Not applicable, Interventional, and Treatment
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.
Hadassah Medical Organization is the lead sponsor of 659 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Drug: oral midazolam
administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Drug: nasal midazolam
administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Also known as: oral dormicum
administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
Also known as: nasal dormicum
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.
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.
| Milestone | Oral Sedation | Nasal Sedation |
|---|---|---|
| Started | 37 | 33 |
| Completed | 30 | 30 |
| Not completed | 7 | 3 |
| Withdrew: Lost to follow-up | 1 | 2 |
| Withdrew: Low cooperation, referral to treatment under general anesthesia | 6 | 1 |
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).
| Participants | Oral Sedation | Nasal Sedation |
|---|---|---|
| willingly | 11 | 4 |
| coaxed | 14 | 18 |
| forced | 5 | 8 |
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
| score on a scale | Oral Sedation | Nasal Sedation |
|---|---|---|
| Behavior During Dental Treatment | 5.17 ± 0.79 | 4.80 ± 0.80 |
Collected over From administering the medication until recovery from sedation- at least 2 hours for each patient. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Oral Sedation | 0/37 (0%) | 0/37 (0%) | 0/37 (0%) |
| Nasal Sedation | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Oral Sedation | Nasal Sedation | Total |
|---|---|---|---|
| Mean | 4.25 ± 1.39 | 4.46 ± 1.25 | 4.36 ± 1.32 |
| Sex: Female, Male(Participants) | Oral Sedation | Nasal Sedation | Total |
|---|---|---|---|
| Female | 15 | 14 | 29 |
| Male | 15 | 16 | 31 |
| Race and Ethnicity Not Collected(Participants) | Oral Sedation | Nasal Sedation | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Oral Sedation | Nasal Sedation | Total |
|---|---|---|---|
| Israel | 30 | 30 | 60 |
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Hadassah Medical Organization