Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children
- Conditions
- AnesthesiaPediatrics
- Interventions
- Other: Inhalation induction with parosmia
- Registration Number
- NCT06449157
- Lead Sponsor
- Johns Hopkins University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- Ages of 5-12 years old
- American Society of Anesthesiologist physical status classification system (ASA) I and II
- Patients coming from home
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Inhalation induction with parosmia 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.
- Primary Outcome Measures
Name Time Method Perioperative anxiety as assessed by the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF) 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 Outcome Measures
Name Time Method Number of antiemetic mediations administered post-operatively immediately after the surgery Measuring statistical difference in 1) number of antiemetic medications administered
Type and total dose of opioids administered post-operatively immediately after the surgery Type and total dose of opioids administered
Length of time (minutes) to post-anesthesia care unit (PACU) discharge 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
Trial Locations
- Locations (1)
Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States