Adults 2 to 9, any sex, with Parental/Caregiver Anxiety or Child's Anxiety. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Patient Anxiety at the Time of SeparationPrimary· Up to 24 hours including preoperative, preoperative, and postoperative periods.
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,
Group
Value
95% CI
Midazolam
26.69
23.30 – 36.60
Zolpidem
30.00
23.30 – 38.20
Mask Acceptance ScoreSecondary· During induction of general anesthesia.
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.
Group
Value
95% CI
Midazolam
34
Zolpidem
29
Midazolam
4
Zolpidem
13
Presence of Emergence Delirium During RecoverySecondary· Up to 30 minutes after child's first eye opening in the post-operative period.
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.
Group
Value
95% CI
Midazolam
26
Zolpidem
32
Midazolam
12
Zolpidem
10
Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)Secondary· Preoperative holding area from the time of informed consent until caregiver/patient separation.
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
STAIY-1 (at informed consent)
Group
Value
95% CI
Midazolam
41.74
± 10.66
Zolpidem
41.12
± 10.88
STAIY-2 (at informed consent)
Group
Value
95% CI
Midazolam
31.81
± 8.29
Zolpidem
34.12
± 8.29
STAIY-1 (at separation)
Group
Value
95% CI
Midazolam
44.33
± 9.58
Zolpidem
43.85
± 13.70
Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score.Secondary· Up to 24 hours including pre-operative, peri-operative and post-operative periods.
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
mYPAS2 - non-anxious baseline
Group
Value
95% CI
Midazolam
23.32
23.30 – 30.80
Zolpidem
28.30
23.30 – 42.50
mYPAS2 - anxious baseline
Group
Value
95% CI
Midazolam
29.97
23.30 – 46.60
Zolpidem
60.75
36.60 – 96.70
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse event data were collected during the study participation time which was about one day for each subject..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by Loma Linda University
Last refreshed: 14 March 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02096900.