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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449157
• Other study ID #: IRB00434506
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Johns Hopkins University
• Contact: Pooja O'Neil, MD
• Phone: 4109556412
• Email: poneil3[@]jh.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 13 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Olfaction Disorders
• Pediatrics

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of antiemetic mediations administered post-operatively	Measuring statistical difference in 1) number of antiemetic medications administered	immediately after the surgery
Secondary	Type and total dose of opioids administered post-operatively	Type and total dose of opioids administered	immediately after the surgery
Secondary	Length of time (minutes) to post-anesthesia care unit (PACU) discharge	Length of time from admission to PACU discharge between the control group and the intervention group	admission to the PACU through discharge from the PACU (<2 hours post-operatively)