Induction in the Dark
ConditionAnesthesia Induction
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age2-6
SponsorMedical University of South Carolina
About this trial
This study will enroll children ages 2-6 who are undergoing an elective outpatient surgical procedure under general anesthesia. They will be randomized to one of the following groups and assessed for preoperative anxiety, mask acceptance, and behavioral changes in the following week.
1. darkened room and star projector with parental presence; 2. preoperative midazolam 0.5 mg/kg by mouth and parental presence; or 3. parental presence alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 2 to 6 years old
American Society of Anesthesiologists physical status I-II
Outpatient elective surgical procedures
Undergoing general anesthesia
Disqualifiers
History of previous surgery
Fear of the dark
Contraindication to inhalational mask induction of general anesthesia such as allergy to inhalation medication, NPO violation, active nausea or vomiting, severe GERD, etc.
Severe developmental delay
Trial design
Design model
Parallel
Treatments tested in this trial
Dark with star projector
Other interventionWhen in the operating room prior to the start of induction, the room will be darkened, and a star projector that lights up the ceiling and walls will be turned on.
Preoperative midazolam
DrugMidazolam by mouth preoperatively.
Parental Presence
Other interventionA parent or guardian will accompany the child into the OR and be present for the start of induction.
Treatment groups
240 Participants
are divided into 3 treatment groupsGroup A: Darkened room and star projector with parental presenceActive comparator 2 interventions
Group B: Preoperative midazolam 0.5 mg/kg po and parental presenceActive comparator 2 interventions
Group C: Parental presence aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Mask acceptance
Mask acceptance during inhalational mask induction as measured by the mask acceptance scale (MAS). The MAS is scored on a scale from 1-4 by evaluating if the child is calm and accepting of the mask (4), slightly scared but easily calmed (3), has moderate fear of the mask and is not easily calmed (2), or cries, screams, or is terrified (1) during induction when using the inhalation mask. A higher score is better.
Time frame
during induction evaluated up until the start of the scheduled surgerySecondary outcomes
1
Perioperative anxiety
Perioperative anxiety will be measured using the modified Yale perioperative anxiety scale (mYpas) at two different time points; the first will be measured preoperatively in holding, and the other will be measured again during the entry to the operating room. The mYpas consists of 22 items, divided into five categories: activity, vocalizations, emotional expressivity, state of apparent arousal, and use of parent. The evaluator will rate the subject in each category (he highest behavioral level observed in each of the five m-YPAS categories is the score for that category), then divide each item rating by the highest possible rating, add all of the produced values, multiply by 100, then divide by 2. The lower the score, the less anxiety the patient is exhibiting.
Time frame
Measured preoperatively, then measured again during the entry to operating room.2
Parental satisfaction of induction experience
After the induction period of anesthesia is over, the parent or guardian who accompanied the child to the operating room and was present for induction will complete a satisfaction survey. There are 6 questions rated from 1-5 (1 being strongly disagree, and 5 being strongly agree) asking how they felt about the induction experience. There is one question asking about how the parent felt about the child's acceptance of the mask during induction. This is rated from 1 (poor) to 4 (excellent). The scores given for each question are added up. Scores can range from 7-29. The higher the score, the better outcome and higher satisfaction.
Time frame
evaluated after child's induction is complete up until the end of surgery3
Post-Operative Emergency Delirium
Once in the PACU, the patient will be evaluated for emergence delirium using the Pediatric Anesthesia Emergence Delirium (PAED) Scale. The evaluator will answer 3 questions about the patient's actions on a scale from 0 (extremely) to not at all (1), then an additional 2 questions about restlessness and inconsolable, scored from 0 (not at all) to 4 (extremely. The scores are added up. The total score can range from 0-20, and the lower the score, the better.
Time frame
from PACU arrival until discharge4
Behavioral Changes
At Day 1 Post-Op and again at Day 7 Post Op, a parent or guardian will answer a series of 27 questions that evaluate the child for behavioral changes occurring post-operatively by using the Post-Hospitalization Behavior Questionnaire (PHBQ). The rating scale for this assessment has 5 response options: (1) less than before (2), same as before (3), more than before (4), and much more than before (5). The answerers are added up with a possible range of 27-135. The lower the score, the less behavioral changes have occurred since the procedure.
Time frame
Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operativelySponsors and contacts
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Source ClinicalTrials.gov