| Primary | Patient Anxiety at Baseline | A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety). | The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm, 2 patients in the placebo arm, and 1 patient in the prospective midazolam arm did not complete this assessment. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (prior to drug administration) | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0001.3± 1.5
- OG0011.4± 1.6
- OG0023.4± 2.7
|
|
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| Secondary | Patient Alertness at Baseline | A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake). | The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment. | Posted | | Mean | Standard Deviation | units on a scale | | Baseline (prior to drug administration) | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Patient Alertness at 60 and 120 Minutes | A 10-point visual analog scale (VAS) was used to measure alertness. The patients marked on the scale their feeling of alertness. The lowest value possible was 0 (awake) and the highest value possible was 10 (barely awake). | The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm and 1 patient in the prospective midazolam arm did not complete this assessment. | Posted | | Mean | Standard Error | units on a scale | | 60 and 120 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Primary | Patient Anxiety at 60 and 120 Minutes | A 10-point visual analog scale (VAS) was used to measure anxiety. The patients marked on the scale their feeling of anxiety. The lowest value possible was 0 (no anxiety) and the highest value possible was 10 (highest possible anxiety). | The analysis was done on the patients who completed the assessment. One patient in the randomized midazolam arm did not complete this assessment. | Posted | | Mean | Standard Deviation | units on a scale | | 60 and 120 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Patient Cognitive Function at Baseline and 60 Minutes | Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function). | The analysis was done on the patients who completed the assessment. One patient in the prospective midazolam arm did not complete this assessment. | Posted | | Mean | Standard Deviation | units on a scale | | baseline (prior to drug administration) and 60 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Patient Cognitive Function at 120 Minutes | Cognitive function was measured by the Mini-Mental State Examination (MMSE), a brief 30 point questionnaire test. The scores can range from 0 (low cognitive function) to 30 (high cognitive function). | The analysis was done on the patients who completed the assessment. Two patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | units on a scale | | 120 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
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| Secondary | Blood Pressure at 30 Minutes | | | Posted | | Mean | Standard Deviation | mm Hg | | 30 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Heart Rate at 30 Minutes | | The analysis was done on the patients who completed the assessment. One patient in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | heart beats per minute | | 30 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Respiratory Rate at 30 Minutes | | The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | breaths per minute | | 30 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Pulse Oximetry at 30 Minutes | Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%. | The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | percentage of oxygenation | | 30 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
|
| Secondary | Blood Pressure at 60 Minutes | | The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | mm Hg | | 60 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Heart Rate at 60 Minutes | | The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 2 patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | heart beats per minute | | 60 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Respiratory Rate at 60 Minutes | | The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | breaths per minute | | 60 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
| |
| Secondary | Pulse Oximetry at 60 Minutes | Pulse oximetry measures the oxygenation of a patient's hemoglobin. A sensor is placed on the patient's finger. Light at red and infrared wavelengths is passed sequentially through the patient to a photodetector. The changing absorbance at each of the two wavelengths is measured, allowing determination of the absorbance. The color of the blood provides a measure of oxygenation (the percentage of hemoglobin molecules bound with oxygen molecules). A healthy young person will probably have an oxygen saturation of 95-99%. | The analysis was done on the patients who completed the assessment. Three patients in the randomized midazolam arm and 3 patients in the placebo arm did not complete this assessment. | Posted | | Mean | Standard Deviation | percentage of oxygenation | | 60 minutes after drug administration | | | | ID | Title | Description |
|---|
| OG000 | Randomized Midazolam | Randomized patients receiving single-dose midazolam syrup | | OG001 | Placebo | Randomized patients receiving placebo syrup | | OG002 | Prospective Midazolam | Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible |
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