Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06449157
Enrollment
50
Registered
2024-06-07
Start date
2024-10-10
Completion date
2025-08-07
Last updated
2025-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pediatrics

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.

Interventions

OTHERInhalation 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.

Sponsors

Johns Hopkins University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 13 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

MeasureTime frameDescription
Type and total dose of opioids administered post-operativelyimmediately after the surgeryType and total dose of opioids administered
Length of time (minutes) to post-anesthesia care unit (PACU) dischargeadmission 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
Number of antiemetic mediations administered post-operativelyimmediately after the surgeryMeasuring statistical difference in 1) number of antiemetic medications administered

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026