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Completed

NCT Number: NCT06449157

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

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.

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Key information

Conditions

Age range

5 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: perioperatively

    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.

Secondary outcomes

  1. Number of antiemetic mediations administered post-operatively

    Time frame: immediately after the surgery

    Measuring statistical difference in 1) number of antiemetic medications administered

  2. Type and total dose of opioids administered post-operatively

    Time frame: immediately after the surgery

    Type and total dose of opioids administered

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

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

    Length of time from admission to PACU discharge between the control group and the intervention group

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 7, 2024
Registry last updated
Aug 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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