Induction in the Dark

Anesthesia Induction Clinical Trial

Official title:

Induction in the Dark: a Prospective Randomized Control Trial for Perioperative Pediatric Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06144177
• Other study ID #: Pro00132312
• Status: Recruiting
• Phase: Phase 4
• Start date: April 16, 2024
• Est. completion date: June 22, 2025

Study information

• Verified date: June 2024
• Source: Medical University of South Carolina
• Contact: Haley Nitchie, MHA
• Phone: 843-792-1869
• Email: nitchie[@]musc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 22, 2025
• Est. primary completion date: June 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria

• Age 2 to 6 years old

• American Society of Anesthesiologists physical status I-II

• Outpatient elective surgical procedures

• Undergoing general anesthesia

• Parent or guardian willing to be present during induction

Exclusion Criteria

• 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

• Severe obvious, preoperative anxiety

• Patients currently using psychiatric medications

• Non-English speaking

Related Conditions & MeSH terms

• Anesthesia Induction

Intervention

Other:
• Dark with star projector
When 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.

Drug:
• Preoperative midazolam
Midazolam by mouth preoperatively.

Other:
• Parental Presence
A parent or guardian will accompany the child into the OR and be present for the start of induction.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	during induction evaluated up until the start of the scheduled surgery
Secondary	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.	Measured preoperatively, then measured again during the entry to operating room.
Secondary	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.	evaluated after child's induction is complete up until the end of surgery
Secondary	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.	from PACU arrival until discharge
Secondary	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.	Day 1 Post-Op and Day 7 Post-Op, up to 30 days post-operatively
Secondary	Time to PACU discharge	The time in recovery will be measured from time in recovery starts, to time of discharge.	time in recovery, up to 30 days post-op