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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| oral sedation | Active Comparator | administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. |
|
| nasal sedation | Active Comparator | administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral midazolam | Drug | administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | the compliance in taking the medication will be assessed at the time of administration and recorded immediately. |
| Measure | Description | Time Frame |
|---|---|---|
| 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.
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39916898 | Derived | Fux-Noy A, Saadi Q, Shmueli A, Halperson E, Ram D, Moskovitz M. Parents' satisfaction and children's acceptance of nasal compared to oral midazolam for sedation in two consecutive pediatric dental treatments: a randomized controlled study. Front Dent Med. 2023 Dec 21;4:1296823. doi: 10.3389/fdmed.2023.1296823. eCollection 2023. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Sedation | administration of 0.5mg/kg oral midazolam. |
| FG001 | Nasal Sedation | administration of 0.2mg/kg nasal midazolam. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 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). |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Count of Participants | Participants | the compliance in taking the medication will be assessed at the time of administration and recorded immediately. |
|
From administering the medication until recovery from sedation- at least 2 hours for each patient
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Avia Fux-Noy | Hadassah School of Dental Medicine, P.O.Box 12272 | +97226776135 | fuxavia@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2016 | Aug 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| nasal midazolam | Drug | administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood. |
|
|
| 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. |
| 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 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). | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | 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). | Number | 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. |
|
|
| 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.
| Posted | Mean | Standard Deviation | score on a scale | 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. |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | 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. | 0 | 33 | 0 | 33 | 0 | 33 |
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| D006571 | Heterocyclic Compounds |