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Trial record 46 of 117 for:    ZOLPIDEM AND AIDS

A Comparison of Midazolam and Zolpidem as Oral Premedication in Children (PedsPreMed)

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ClinicalTrials.gov Identifier: NCT02096900
Recruitment Status : Completed
First Posted : March 26, 2014
Results First Posted : August 11, 2017
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Davinder Ramsingh, MD, Loma Linda University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Parental/Caregiver Anxiety
Child's Anxiety
Interventions Drug: zolpidem
Drug: Midazolam
Enrollment 86
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description midazolam was given at 0.5mg/kg, pre-operatively single dose zolpidem was given orally 0.25mg/kg pre-operatively single dose
Period Title: Overall Study
Started 42 [1] 44 [2]
Completed 38 42
Not Completed 4 2
Reason Not Completed
Did not receive medication             3             1
Surgery cancelled- medication received             1             1
[1]
Allocated to Midazolam
[2]
Allocated to Zolpidem
Arm/Group Title Midazolam Zolpidem Total
Hide Arm/Group Description midazolam was given at 0.5mg/kg, pre-operatively single dose zolpidem was given orally 0.25mg/kg pre-operatively single dose Total of all reporting groups
Overall Number of Baseline Participants 38 42 80
Hide Baseline Analysis Population Description
Analyses subjects who completed the study per protocol
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 38 participants 42 participants 80 participants
6.34  (2.21) 6.07  (2.34) 6.20  (2.27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
Female
21
  55.3%
19
  45.2%
40
  50.0%
Male
17
  44.7%
23
  54.8%
40
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
Hispanic or Latino
22
  57.9%
25
  59.5%
47
  58.8%
Not Hispanic or Latino
16
  42.1%
17
  40.5%
33
  41.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
   2.6%
0
   0.0%
1
   1.3%
Native Hawaiian or Other Pacific Islander
1
   2.6%
0
   0.0%
1
   1.3%
Black or African American
0
   0.0%
2
   4.8%
2
   2.5%
White
36
  94.7%
40
  95.2%
76
  95.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 38 participants 42 participants 80 participants
38
 100.0%
42
 100.0%
80
 100.0%
Weight (kg)  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 38 participants 42 participants 80 participants
23.16  (6.20) 23.18  (7.21) 23.17  (6.71)
Height (cm)  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 38 participants 42 participants 80 participants
117.32  (14.55) 115.34  (15.92) 116.29  (15.23)
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 38 participants 42 participants 80 participants
16.73  (1.92) 17.60  (4.02) 17.19  (3.21)
ASA physical status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 38 participants 42 participants 80 participants
ASA PS I
12
  31.6%
14
  33.3%
26
  32.5%
AS PS II
26
  68.4%
28
  66.7%
54
  67.5%
[1]
Measure Description:

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.

Time from drug administration to parental separation (minutes)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 38 participants 42 participants 80 participants
31.53  (12.20) 34.98  (16.00) 33.13  (14.31)
Duration of anesthesia (minutes)  
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 38 participants 42 participants 80 participants
185.58  (72.20) 205.79  (97.60) 196.46  (86.86)
1.Primary Outcome
Title Patient Anxiety at the Time of Separation
Hide Description

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.

Time Frame Up to 24 hours including preoperative, preoperative, and postoperative periods.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description:
midazolam was given at 0.5mg/kg, pre-operatively single dose
zolpidem was given orally 0.25mg/kg pre-operatively single dose
Overall Number of Participants Analyzed 38 42
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
26.69
(23.30 to 36.60)
30.00
(23.30 to 38.20)
2.Secondary Outcome
Title Mask Acceptance Score
Hide Description

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.

Time Frame During induction of general anesthesia.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description:
midazolam was given at 0.5mg/kg, pre-operatively single dose
zolpidem was given orally 0.25mg/kg pre-operatively single dose
Overall Number of Participants Analyzed 38 42
Measure Type: Count of Participants
Unit of Measure: Participants
Mask acceptance score 1-2
34
  89.5%
29
  69.0%
Mask acceptance score 3-4
4
  10.5%
13
  31.0%
3.Secondary Outcome
Title Presence of Emergence Delirium During Recovery
Hide Description 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.
Time Frame Up to 30 minutes after child's first eye opening in the post-operative period.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description:
midazolam was given at 0.5mg/kg, pre-operatively single dose
zolpidem was given orally 0.25mg/kg pre-operatively single dose
Overall Number of Participants Analyzed 38 42
Measure Type: Count of Participants
Unit of Measure: Participants
No
26
  68.4%
32
  76.2%
Yes
12
  31.6%
10
  23.8%
4.Secondary Outcome
Title Parental/Caregiver Anxiety Assessed Using the Validated State-Trait Anxiety Inventory for Adults (STAI)
Hide Description

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.

Time Frame Preoperative holding area from the time of informed consent until caregiver/patient separation.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description:
midazolam was given at 0.5mg/kg, pre-operatively single dose
zolpidem was given orally 0.25mg/kg pre-operatively single dose
Overall Number of Participants Analyzed 24 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
STAIY-1 (at informed consent) 41.74  (10.66) 41.12  (10.88)
STAIY-2 (at informed consent) 31.81  (8.29) 34.12  (8.29)
STAIY-1 (at separation) 44.33  (9.58) 43.85  (13.70)
5.Post-Hoc Outcome
Title Modified Yale Preoperative Anxiety Scale (mYPAS) Score at Separation (mYPAS2) Based on Baseline (mYPAS1) Score.
Hide Description

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.

Time Frame Up to 24 hours including pre-operative, peri-operative and post-operative periods.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description:
midazolam was given at 0.5mg/kg, pre-operatively single dose
zolpidem was given orally 0.25mg/kg pre-operatively single dose
Overall Number of Participants Analyzed 38 42
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
mYPAS2 - non-anxious baseline
23.32
(23.30 to 30.80)
28.30
(23.30 to 42.50)
mYPAS2 - anxious baseline
29.97
(23.30 to 46.60)
60.75
(36.60 to 96.70)
Time Frame Adverse event data were collected during the study participation time which was about one day for each subject.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Midazolam Zolpidem
Hide Arm/Group Description midazolam was given at 0.5mg/kg, pre-operatively single dose zolpidem was given orally 0.25mg/kg pre-operatively single dose
All-Cause Mortality
Midazolam Zolpidem
Affected / at Risk (%) Affected / at Risk (%)
Total   0/38 (0.00%)      0/42 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Midazolam Zolpidem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/38 (0.00%)      0/42 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Midazolam Zolpidem
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/38 (2.63%)      5/42 (11.90%)    
Gastrointestinal disorders     
Epigastric pain * [1]  0/38 (0.00%)  0 1/42 (2.38%)  1
Nervous system disorders     
Double vision *  0/38 (0.00%)  0 2/42 (4.76%)  2
Visual Hallucinations *  0/38 (0.00%)  0 2/42 (4.76%)  2
Involuntary tongue movements *  0/38 (0.00%)  0 1/42 (2.38%)  1
Dysphoria * [2]  0/38 (0.00%)  0 1/42 (2.38%)  1
Respiratory, thoracic and mediastinal disorders     
Oxygen desatruation * [3]  1/38 (2.63%)  1 0/42 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Epigastric pain. Likely related to preoperative fasting rather than the investigational drug.
[2]
Unpleasant sensation after taking the medication
[3]
Oxygen desaturation with pulse oximeter reading less than 94% for 33 seconds (SPO2 range 87-94%). Resolved when deep breathing was encouraged.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Amgad H. Hanna, MD
Organization: Loma Linda University
Phone: 909-558-4475
Responsible Party: Davinder Ramsingh, MD, Loma Linda University
ClinicalTrials.gov Identifier: NCT02096900     History of Changes
Other Study ID Numbers: 5140032
First Submitted: March 24, 2014
First Posted: March 26, 2014
Results First Submitted: April 19, 2017
Results First Posted: August 11, 2017
Last Update Posted: March 14, 2019