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

NCT06449157 | Completed

• 1 other identifier: IRB00434506
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Perioperative anxiety as assessed by the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF)

  The modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) will be used to evaluate perioperative anxiety. Patients are evaluated in 4 domains: activity (score 1,2,3, or 4), vocalizations (score 1,2,3,4,5 or 6), emotional expressivity (1,2,3 or 4), and state of apparent arousal (1,2,3, or 4), with higher numbers indicating the highest severity within that item. Each score is calculated by dividing each item rating by the highest possible rating (i.e., 6 for the "vocalizations" item and 4 for all other items), adding all the produced values, dividing by 5, and multiplying by 100. This calculation produces a score ranging from 23.33 to 100, with higher values indicating higher anxiety.

  perioperatively

Secondary Outcomes (3)

• Number of antiemetic mediations administered post-operatively

  immediately after the surgery

• Type and total dose of opioids administered post-operatively

  immediately after the surgery

• Length of time (minutes) to post-anesthesia care unit (PACU) discharge

  admission to the PACU through discharge from the PACU (<2 hours post-operatively)

Study Arms (2)

Inhalation induction with parosmia

EXPERIMENTAL

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.

Other: Inhalation induction with parosmia

Standard inhalation induction

NO INTERVENTION

Standard inhalation induction.

Interventions

Inhalation induction with parosmia 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.

Inhalation induction with parosmia

Eligibility Criteria

• Age: 5 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

• Pooja O'Neil, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 7, 2024
• Study Start: October 10, 2024
• Primary Completion: August 7, 2025
• Study Completion: August 7, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)