Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children

NCT ID: NCT06449157

Last Updated: 2025-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-10
• Study Completion Date: 2025-08-07

Brief Summary

Children undergoing surgery and anesthesia are often negatively impacted by anxiety and fear in the preoperative period. Routine inhalational anesthetic induction is a unique aspect of pediatric anesthesia. Inhalation inductions are usually initiated with sevoflurane with or without nitrous oxide. While less pungent than other volatile agents, sevoflurane at high concentrations and flows used for inhalation inductions still causes children to often repel from the smell. This can lead to an unpleasant interaction and cause heightened anxiety for any subsequent procedures.

Olfactory senses are processed in the hippocampus and amygdala and tied to emotion and memory. Parosmia is the distortion of smell perception which can utilized to the pediatric anesthesiologists advantage. It has been demonstrated that using this phenomenon, the anesthesiologist can induce a better smell for the child leading to improved cooperation during an inhalation induction. However, limitations of this study include lack of randomization, small sample size, and use of a nominal scale of yes or no for face mask acceptance. The investigators identified no other studies to validate this potentially powerful tool to optimize anesthetic induction for pediatric patients.

The overall objective of this pilot randomized trial is to determine the feasibility of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia during inhalation inductions to decrease perioperative stress for children and provide key pilot data to power a larger study to determine effectiveness of parosmia.

Conditions

Anesthesia; Pediatrics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Inhalation induction with parosmia

The experimental group will be told about a magical machine that can change the smell of the mask to any flavor the patient desires. The participant will be asked to take a deep breath thinking about that smell and then sevoflurane will be introduced. The patient will be asked if the the chosen flavor is smelled and the response will be noted.

Group Type: EXPERIMENTAL

Inhalation induction with parosmia

Intervention Type: OTHER

The experimental group will then be told that the patient's favorite smell will be put into the face mask via the "magical machine". The patient will be asked to take a deep breath thinking about that smell and then introduce sevoflurane. The patient will be asked if the chosen flavor is smelled and their response will be noted.

Standard inhalation induction

Standard inhalation induction.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Inhalation induction with parosmia

The experimental group will then be told that the patient's favorite smell will be put into the face mask via the "magical machine". The patient will be asked to take a deep breath thinking about that smell and then introduce sevoflurane. The patient will be asked if the chosen flavor is smelled and their response will be noted.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Ages of 5-12 years old
• American Society of Anesthesiologist physical status classification system (ASA) I and II
• Patients coming from home

Exclusion Criteria

• Patients undergoing emergent surgery
• Patients who have not adequately maintained preoperative nothing per mouth/os (NPO) status
• Patients with inability to communicate verbally
• Tracheostomy patients
• ASA III , IV, V patients

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pooja O'Neil, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins School of Medicine

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

IRB00434506

Identifier Type: -

Identifier Source: org_study_id