Trial · NCT02096900

A Comparison of Midazolam and Zolpidem as Oral Premedication in Children

NCT02096900, Phase 3, Completed, Loma Linda University; results first posted 2017-08-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Comparison of Midazolam and Zolpidem as Oral Premedication in Children. Trials, record NCT02096900. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02096900

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Comparison of Midazolam and Zolpidem as Oral Premedication in Children
NCT number: NCT02096900
Status: Completed
Phases: Phase 3
Enrollment: 86 participants, actual
Lead sponsor: Loma Linda University
Conditions: Parental/Caregiver Anxiety, Child's Anxiety
Interventions: zolpidem, Midazolam
First posted: 2014-03-26
Last updated: 2019-03-14
Results first posted: 2017-08-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Patient Anxiety at the Time of Separation	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, 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.
Secondary	Mask Acceptance Score	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.
Secondary	Presence of Emergence Delirium During Recovery	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.
Secondary	Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)	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 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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patient Anxiety at the Time of Separation	Up to 24 hours including preoperative, preoperative, and postoperative periods.		units on a scale	MEDIAN
SECONDARY	Mask Acceptance Score	During induction of general anesthesia.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Presence of Emergence Delirium During Recovery	Up to 30 minutes after child's first eye opening in the post-operative period.		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)	Preoperative holding area from the time of informed consent until caregiver/patient separation.	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.	units on a scale	MEAN
POST_HOC	Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score.	Up to 24 hours including pre-operative, peri-operative and post-operative periods.		units on a scale	MEDIAN

Source ClinicalTrials.gov

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Patient Anxiety at the Time of Separation	Midazolam		26.69	Inter-Quartile Range 23.30 to 36.60	units on a scale
Patient Anxiety at the Time of Separation	Zolpidem		30.00	Inter-Quartile Range 23.30 to 38.20	units on a scale
Mask Acceptance Score	Midazolam	Mask acceptance score 1-2	34		Participants
Mask Acceptance Score	Zolpidem	Mask acceptance score 1-2	29		Participants
Mask Acceptance Score	Midazolam	Mask acceptance score 3-4	4		Participants
Mask Acceptance Score	Zolpidem	Mask acceptance score 3-4	13		Participants
Presence of Emergence Delirium During Recovery	Midazolam	No	26		Participants
Presence of Emergence Delirium During Recovery	Zolpidem	No	32		Participants
Presence of Emergence Delirium During Recovery	Midazolam	Yes	12		Participants
Presence of Emergence Delirium During Recovery	Zolpidem	Yes	10		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Midazolam	42
Overall Study	STARTED	Zolpidem	44
Overall Study	COMPLETED	Midazolam	38
Overall Study	COMPLETED	Zolpidem	42
Overall Study	NOT COMPLETED	Midazolam	4
Overall Study	NOT COMPLETED	Zolpidem	2

Source ClinicalTrials.gov

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Oxygen desatruation	Respiratory, thoracic and mediastinal disorders	Midazolam	1	38	1
other	Oxygen desatruation	Respiratory, thoracic and mediastinal disorders	Zolpidem	0	42	0
other	Double vision	Nervous system disorders	Midazolam	0	38	0
other	Double vision	Nervous system disorders	Zolpidem	2	42	2
other	Epigastric pain	Gastrointestinal disorders	Midazolam	0	38	0
other	Epigastric pain	Gastrointestinal disorders	Zolpidem	1	42	1
other	Visual Hallucinations	Nervous system disorders	Midazolam	0	38	0
other	Visual Hallucinations	Nervous system disorders	Zolpidem	2	42	2
other	Involuntary tongue movements	Nervous system disorders	Midazolam	0	38	0
other	Involuntary tongue movements	Nervous system disorders	Zolpidem	1	42	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Midazolam	0	38
Total, all-cause mortality	Zolpidem	0	42
Total, other adverse events	Midazolam	1	38
Total, other adverse events	Zolpidem	5	42
Total, serious adverse events	Midazolam	0	38
Total, serious adverse events	Zolpidem	0	42

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Midazolam vs Zolpidem: deaths from any cause	Trial comparisons
Midazolam vs Zolpidem: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT02096900/registered

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