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The purpose of this investigator-initiated study is to compare the efficacy of oral midazolam and zolpidem for preoperative sedation, anxiety of patient, and caregiver anxiety at the time of separation, and ease of mask acceptance at induction in children. Subjects will be randomized to receive oral medication midazolam or zolpidem approximately 30 minutes prior to surgery. No placebo will be administered in this study. Subjects will be male and female children between 2 and 9 years of age. In total, subject participation will last approximately the duration of their preoperative, perioperative, and immediate postoperative period. A member of the research team will recruit subjects preoperatively in the operating room holding area prior to surgery. Consent will take place at the time of recruitment in the preoperative holding area following a detailed explanation of the study and medications involved in the study. Participants will be of ASA (American Society of Anesthesiologists) class I-II, undergoing surgical procedures of at least 2 hours duration, and expected to remain inpatient for at least 23 hours postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| zolpidem | Active Comparator | zolpidem given orally 0.25mg/kg pre-operatively single dose |
|
| midazolam | Active Comparator | midazolam will be given at 0.5mg/kg, pre-operatively single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| zolpidem | Drug | Zolpidem will be given one time at 0.25 mg/kg pre-operatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Anxiety at the Time of Separation | The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious. | Up to 24 hours including preoperative, preoperative, and postoperative periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Mask Acceptance Score | Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial. Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia. | During induction of general anesthesia. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Amgad Hanna, MD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92354 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Midazolam | midazolam was given at 0.5mg/kg, pre-operatively single dose |
| FG001 | Zolpidem | zolpidem was given orally 0.25mg/kg pre-operatively single dose |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analyses subjects who completed the study per protocol
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| ID | Title | Description |
|---|---|---|
| BG000 | Midazolam | midazolam was given at 0.5mg/kg, pre-operatively single dose |
| BG001 | Zolpidem | zolpidem was given orally 0.25mg/kg pre-operatively single dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Patient Anxiety at the Time of Separation | The primary outcome measure of patient anxiety will be measured using the validated Modified Yale Preoperative Anxiety Score (mYPAS). The mYPAS is the current standard for evaluation of anxiety in children receiving anesthesia for surgical procedures. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children. It was developed by the study group lead by Kain Z. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious. | Posted | Median | Inter-Quartile Range | units on a scale | Up to 24 hours including preoperative, preoperative, and postoperative periods. |
|
Adverse event data were collected during the study participation time which was about one day for each subject.
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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 | Midazolam | midazolam was given at 0.5mg/kg, pre-operatively single dose | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oxygen desatruation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Oxygen desaturation with pulse oximeter reading less than 94% for 33 seconds (SPO2 range 87-94%). Resolved when deep breathing was encouraged. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Amgad H. Hanna, MD | Loma Linda University | 909-558-4475 | ahanna@llu.edu |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001569 | Benzodiazepines |
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| Midazolam | Drug |
|
|
| Presence of Emergence Delirium During Recovery |
Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium. |
| Up to 30 minutes after child's first eye opening in the post-operative period. |
| Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI) | Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment". The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress). The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety. After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver. | Preoperative holding area from the time of informed consent until caregiver/patient separation. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| ASA physical status | The American Society of Anesthesiologists (ASA) physical status classification system provides assessment of the fitness of patients before surgery. ASA PS I patient is a normal healthy patient. ASA PS II patient is a patient with mild systemic disease without substantive functional limitations, for example; well controlled diabetes/hypertension or mid lung disease. | Count of Participants | Participants |
|
| Time from drug administration to parental separation (minutes) | Mean | Standard Deviation | minutes |
|
| Duration of anesthesia (minutes) | Mean | Standard Deviation | minutes |
|
midazolam was given at 0.5mg/kg, pre-operatively single dose |
| OG001 | Zolpidem | zolpidem was given orally 0.25mg/kg pre-operatively single dose |
|
|
| Secondary | Mask Acceptance Score | Mask acceptance by the patient, will be measured on a 4-point scale adapted from a similar trial. Score of 1 and 2 indicates satisfactory mask acceptance. Score of 3 or 4 indicates unsatisfactory mask acceptance during induction of general anesthesia. | Posted | Count of Participants | Participants | During induction of general anesthesia. |
|
|
|
| Secondary | Presence of Emergence Delirium During Recovery | Presence or absence of emergence delirium during recovery, will be assessed using the pediatric anesthesia emergence delirium (PAED) scale recorded at 5-minute intervals for 20 minutes following the child's spontaneous eye opening. PAED score of ≥12 at any time indicates presence of emergence delirium. | Posted | Count of Participants | Participants | Up to 30 minutes after child's first eye opening in the post-operative period. |
|
|
|
| Secondary | Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI) | Parental/caregiver anxiety, was assessed using the validated State-Trait Anxiety Inventory for Adults (STAI), a validated self-evaluation questionnaire. The STAI is compromised of separate self-report scales for measuring state and trait anxiety. The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment". The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how respondents generally feel. The score ranges from 20 (most relaxed) to 80 (highest stress). The baseline STAI inventory was completed by e parent/caregiver after obtaining the informed consent in the preoperative holding area and before the subject was separated from the caregiver. Baseline STAI inventory consisted of form STAIY-1 (State Anxiety) and form STAIY-2 (Trait Anxiety) anxiety. After caregiver/patient separation,form STAIY-1(State Anxiety) was completed again by the caregiver. | only total of 51 subjects were analyzed. Caregivers of 29 subjects were given incorrect form to fill at time of separation rendering data not applicable for analysis for the 29 subjects. | Posted | Mean | Standard Deviation | units on a scale | Preoperative holding area from the time of informed consent until caregiver/patient separation. |
|
|
|
| Post-Hoc | Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score. | Midazolam group participants will be separated into two groups; non-anxious (mYPAS1 ≤ 30) at baseline and anxious (mYPAS1 > 30) at baseline. The mYAPS2 scores of these two groups will be compared to the mYPAS2 scores of the Zolpidem group participants. The modified Yale Preoperative Anxiety scale (m-YPAS) is a structured observational measure of preoperative anxiety in children that takes less than a minute to preform. It consists of assessment of 27 items in 5 domains of behavior indicating anxiety in young children; activity, emotional expressivity, state of arousal, vocalization, and use of parents. Each item is weighted in calculation of the total score that ranges from 22.5 -100. A cut off 30 on the m-YPAS scale was found to balance the high specificity and sensitivity while maintaining high positive predictive value. Children with a score above 30 are considered anxious while those with the score of 30 or less were considered not anxious. | Posted | Median | Inter-Quartile Range | units on a scale | Up to 24 hours including pre-operative, peri-operative and post-operative periods. |
|
|
|
| 38 |
| 0 |
| 38 |
| 1 |
| 38 |
| EG001 | Zolpidem | zolpidem was given orally 0.25mg/kg pre-operatively single dose | 0 | 42 | 0 | 42 | 5 | 42 |
|
| Double vision | Nervous system disorders | Non-systematic Assessment |
|
| Epigastric pain | Gastrointestinal disorders | Non-systematic Assessment | Epigastric pain. Likely related to preoperative fasting rather than the investigational drug. |
|
| Visual Hallucinations | Nervous system disorders | Non-systematic Assessment |
|
| Involuntary tongue movements | Nervous system disorders | Non-systematic Assessment |
|
| Dysphoria | Nervous system disorders | Non-systematic Assessment | Unpleasant sensation after taking the medication |
|
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| D001552 |
| Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| STAIY-1 (at separation) |
|