Language During Inhalational Induction

Emergence Delirium Clinical Trial

Official title:

A Prospective Randomized Study Comparing Positive Language vs Common Language During Inhalational Induction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06324955
• Other study ID #: IRB-P00042507
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: March 11, 2025

Study information

• Verified date: March 2024
• Source: Boston Children's Hospital
• Contact: John Fiadjoe, MD
• Phone: 617-355-7737
• Email: john.fiadjoe[@]childrens.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 128
• Est. completion date: March 11, 2025
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• ASA 1 and 2 (Healthy Patients)

• Non-emergent cases

• 5-10 year olds

• Patients receiving inhalational induction

Exclusion Criteria:

• Non-English speaking

• History of prior inhalational inductions

• Hearing difficulty

• Behavioral difficulty (Autism, Oppositional Defiant Disorder)

• Patients receiving premedication other than midazolam

Related Conditions & MeSH terms

• Anesthesia; Adverse Effect
• Emergence Delirium

Intervention

Behavioral:
• Standard/common language during induction
The anesthesiologist taking care of the patient will use scripted common/standard language during the induction.
• Positive language during induction
The anesthesiologist taking care of the patient will use scripted positive language during the induction.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Induction compliance	Compliance of children during mask induction as measured by the Induction Compliance Checklist (ICC) from the time patient enters the operating room until loss of lid reflex	Through Study Completion about 1 day
Secondary	Length of induction	Time from start of induction to loss of lid reflex	Through Study Completion about 1 day
Secondary	Verbal refusal of mask	Patient verbal expression of refusal of the mask during start of induction until loss of lid reflex	Through Study Completion about 1 day