Clinical trial NCT06449157: Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children
Official title: Chocolate or Sevoflurane: Use of Parosmia to Facilitate More Cooperative Inhalation Inductions in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesia
Pediatrics
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2024-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Perioperative anxiety as assessed by the Modified Yale Preoperative Anxiety Scale-Short Form (mYPAS-SF)
timeFrame: perioperatively
Secondary outcomes:
measure: Number of antiemetic mediations administered post-operatively
timeFrame: immediately after the surgery
measure: Type and total dose of opioids administered post-operatively
timeFrame: immediately after the surgery
measure: Length of time (minutes) to post-anesthesia care unit (PACU) discharge
timeFrame: admission to the PACU through discharge from the PACU (<2 hours post-operatively)
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Pooja O'Neil, MD
role: PRINCIPAL_INVESTIGATOR
References: