Parosmia for Pediatric Anesthesia

Overseen By Colleen Mennie, RN

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Emergent surgery, NPO status, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: perioperative period

50 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Inhalation induction with parosmia, Sevorane, Sojourn, Ultane for pediatric anesthesia?

Research shows that sevoflurane, a component of the treatment, is effective for inhalation induction in children due to its non-irritating smell and quick action. Additionally, modifying the smell of anesthetics can improve the experience for children, making them more comfortable during the procedure. ^{1 2 3 4 5}

Is sevoflurane safe for use in pediatric anesthesia?

Sevoflurane is commonly used for pediatric anesthesia due to its quick induction and recovery, but it can cause side effects like seizures and emergence delirium. It may also lead to more respiratory issues compared to intravenous methods, especially in children with existing risk factors. ^{6 7 8 9 10}

How does the drug for parosmia in pediatric anesthesia differ from other treatments?

The treatment uses sevoflurane, a volatile anesthetic, in a unique way by modifying the smell to make it more pleasant for children, which can help them tolerate the induction process better. This approach is different because it focuses on improving the sensory experience of the child during anesthesia induction. ^{1 2 3 4 11}

Research Team

Pooja O'Neil, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for children aged 5-12 who are in good health (ASA I and II) and coming from home. It's designed to see if changing the smell of anesthesia can make kids less scared when they're put to sleep for surgery.

Inclusion Criteria

I am between 5 and 12 years old.

I am currently living at home.

I am in good or mild systemic disease according to ASA classification.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo inhalation induction with either parosmia or standard method

perioperative period

1 visit (in-person)

Follow-up

Participants are monitored for perioperative anxiety and post-operative outcomes

<2 hours post-operatively

1 visit (in-person)

Treatment Details

Interventions

• Inhalation induction with parosmia

Trial Overview The study tests whether using parosmia, which changes how smells are perceived, can help kids cooperate better during inhalation inductions with sevoflurane—anesthesia gas—by making it smell nicer.

Participant Groups

Group I: Inhalation induction with parosmia Experimental Treatment 1 Intervention

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.

Group II: Standard inhalation induction Active Control 1 Intervention

Standard inhalation induction.

Inhalation induction with parosmia is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Sevorane for:

• Induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery

Approved in European Union as Sevorane for:

• Induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery

Approved in Canada as Sevorane for:

• Induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery

Approved in Japan as Sevorane for:

• Induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

In a study involving 41 children aged 3-10 years, using fruit flavoring to disguise the odor of isoflurane during inhalational induction resulted in significantly quieter behavior compared to a placebo, although movement levels remained unchanged.

Despite the improvement in quietness, there were no differences in respiratory complications or overall quality of induction as assessed by the anaesthetist, indicating that while the flavoring may help with comfort, its impact on safety and efficacy needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Fruit-flavoured' mask for isoflurane induction in children. Lewis, RP., Jones, MJ., Eastley, RJ., et al.[2013]

A new method called troposmia was developed to help children enjoy the smell of sevoflurane during inhalational induction, resulting in significantly fewer children resisting the facemask (1 out of 32 in the troposmia group compared to 9 out of 32 in the control group).

Most children in the troposmia group reported that the smell of the facemask changed as they requested, indicating that this technique can enhance their experience and cooperation during anesthesia induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distorted perception of smell by volatile agents facilitated inhalational induction of anesthesia. Fukumoto, M., Arima, H., Ito, S., et al.[2018]

In a study involving 120 pediatric patients aged 3 to 10 years, sevoflurane at a concentration of 6% was found to provide a faster induction of anesthesia with fewer adverse effects compared to higher concentrations.

While higher concentrations of sevoflurane (8%) led to a higher incidence of airway reflex responses, the decrease in blood pressure remained within a safe range across all concentrations, indicating that 6% is the most practical choice for effective and safe inhalation induction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inhalation induction with 2%, 4%, 6%, and 8% sevoflurane in nitrous oxide for pediatric patients. Hsu, YW., Pan, MH., Huang, CJ., et al.[2018]

In a study involving 30 children aged 3-7 years, it was found that a lower concentration of sevoflurane is needed for laryngeal mask insertion (1.53%) compared to tracheal intubation (2.35%).

This suggests that sevoflurane is effective for both procedures, but using it for laryngeal mask insertion may be safer and require less anesthetic, which is beneficial in pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[End-tidal sevoflurane concentrations for laryngeal mask airway insertion and tracheal intubation in children]. Grabowska-Gaweł, A.[2018]

In a study of 64 children aged 3-12 undergoing surgery, sevoflurane provided a faster recovery from anesthesia compared to halothane, with shorter times for purposeful movements (9 min vs. 15.5 min) and readiness for discharge (18 min vs. 30 min).

Sevoflurane also demonstrated better cardiovascular stability during induction, making it a potentially safer alternative to halothane for pediatric anesthesia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective, randomized clinical comparison of sevoflurane and halothane in children. Villani, A., Zuccoli, P., Rovella, C., et al.[2018]

Sevoflurane is preferred over halothane for pediatric anesthesia due to its rapid induction and recovery, nonpungent odor, and reduced airway irritation, which lowers the risk of bronchospasm and laryngospasm.

However, sevoflurane can cause side effects such as seizures, increased plasma inorganic fluoride levels, and a higher incidence of emergence delirium compared to halothane, highlighting the need for awareness among perianesthesia nurses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sevoflurane and emergence behavioral changes in pediatrics. Moos, DD.[2019]

A systematic review of four randomized controlled trials involving pediatric anesthesia found no significant difference in perioperative respiratory adverse events between inhalational and intravenous induction methods.

However, inhalational induction was associated with a higher risk of respiratory adverse events in children with multiple risk factors, suggesting that careful consideration is needed when choosing induction methods for at-risk pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Respiratory and hemodynamic perioperative adverse events in intravenous versus inhalational induction in pediatric anesthesia: A systematic review and meta-analysis. Porter, LL., Blaauwendraad, SM., Pieters, BM.[2021]

Using a portable inhalational anesthetic circuit for sevoflurane induction outside the operating room (OR) in 100 children resulted in significantly faster anesthesia induction and awakening times compared to ketamine, with times of 28 seconds and 11.2 seconds respectively.

The sevoflurane group experienced less anxiety during induction (10% noncooperation) and showed better vital signs, including lower heart rates and higher oxygen saturation levels, indicating that this method is both safe and effective for pediatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of sevoflurane anesthesia induction with a portable inhalational anesthetic circuit in pediatric patients. Yu, M., Han, C., Zhou, Q., et al.[2020]

In a study involving 102 pediatric patients, sevoflurane was found to have a higher incidence of emergence agitation compared to halothane during recovery from anesthesia, indicating a potential drawback in its use for pediatric procedures.

Despite its rapid induction and recovery benefits, the study highlights the need for caution with sevoflurane due to its association with postoperative excitement, which may affect patient comfort after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sevofluran in pediatric practice--personal experience]. Kobylarz, K., Kołaczyk, D., Stańczyk, M.[2018]

In a study involving 143 adult patients, sevoflurane was found to allow for a quicker recovery from general anesthesia compared to isoflurane, with shorter times for extubation, eye opening, and command response.

Both sevoflurane and isoflurane demonstrated similar safety profiles, as there were no significant differences in renal and hepatic function before and after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance and recovery characteristics of sevoflurane anaesthesia in adult patients. A multicenter, randomized comparison with isoflurane. Ranieri, R., Martinelli, G., Pagani, I., et al.[2018]

In a study of 27,258 pediatric cases, the overall incidence of hypoxemia following inhalation induction of anesthesia was found to be 5.08%, with younger patients and those with higher ASA scores at greater risk.

The risk of hypoxemia significantly increases when the inspired oxygen concentration is below 60%, highlighting the importance of maintaining higher oxygen levels during anesthesia induction to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of post-induction hypoxemia in children and the effect of induction gas composition. Cumin, D., Baker, PA., Anderson, BJ.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

'Fruit-flavoured' mask for isoflurane induction in children. [2013]

2. France pubmed.ncbi.nlm.nih.gov

Distorted perception of smell by volatile agents facilitated inhalational induction of anesthesia. [2018]

3. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Comparison of inhalation induction with 2%, 4%, 6%, and 8% sevoflurane in nitrous oxide for pediatric patients. [2018]

4. Poland pubmed.ncbi.nlm.nih.gov

[End-tidal sevoflurane concentrations for laryngeal mask airway insertion and tracheal intubation in children]. [2018]

5. Italy pubmed.ncbi.nlm.nih.gov

A prospective, randomized clinical comparison of sevoflurane and halothane in children. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Sevoflurane and emergence behavioral changes in pediatrics. [2019]

7. France pubmed.ncbi.nlm.nih.gov

Respiratory and hemodynamic perioperative adverse events in intravenous versus inhalational induction in pediatric anesthesia: A systematic review and meta-analysis. [2021]

8. Poland pubmed.ncbi.nlm.nih.gov

Clinical effects of sevoflurane anesthesia induction with a portable inhalational anesthetic circuit in pediatric patients. [2020]

9. Poland pubmed.ncbi.nlm.nih.gov

[Sevofluran in pediatric practice--personal experience]. [2018]

10. Italy pubmed.ncbi.nlm.nih.gov

Maintenance and recovery characteristics of sevoflurane anaesthesia in adult patients. A multicenter, randomized comparison with isoflurane. [2018]

11. France pubmed.ncbi.nlm.nih.gov

Incidence of post-induction hypoxemia in children and the effect of induction gas composition. [2021]