Hypersensitivity Reactions to Propofol in Children

Study Overview
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Brief Summary
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The investigators would only include the children who received propofol (Propolipid, Fresenius Kabi, Schelle, Belgium) for sedation, the investigators would exclude the children that didn't receive propofol during the procedure. The investigators would analyze the incidence of hypersensitivity reaction to propofol in children allergic to egg, soy or both egg and soy and to compare those with the incidence of hypersensitivity reactions in children without allergy to egg and/or to soy. Those data were retrieved following longitudinal follow-up after the intervention. Allergy tests by skin and radioallergosorbent tests were performed in all children before the gastrointestinal endoscopy under anesthesia took place, but no results were known at the time of the sedation. A patient was defined as allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L). The investigators would also investigate the influence of other obtained parameters in the dataset (age, ASA score, weight category, type of investigation, respiratory and neurological comorbidities, respiratory infections, GERD, other allergies) on those results with multivariate analysis. We considered that clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations. Depending on the severity of the reaction, necessitating prompt hemodynamic resuscitation with the administration of epinephrine, antihistamines, inhaled beta-agonists or corticosteroids.

Official Title
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Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy

Conditions
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Hypersensitivity, Allergy, Egg, Soy Allergy

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnostic gastrointestinal endoscopy monitored anesthesia received propofol during the procedure allergic to egg and/or soy if the patient had specific S-IgE level more than the normal level set by our institution (0.35 kU/L) Exclusion Criteria: Procedure without administration of propofol

Ages Eligible for Study
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Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Propofol<br> | Drug: Propofol<br>* Perioperatively propofol administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with a hypersensitivity reaction | clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations. | minutes, during surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of gender on hypersensitivity reaction | See if there is a link or influence of gender on hypersensitivity reaction | minutes, during surgery | 
| Influence of ASA on hypersensitivity reaction | See if there is a link or influence of ASA on hypersensitivity reaction | minutes, during surgery | 
| Influence of type of procedure on hypersensitivity reaction | See if there is a link or influence of type of procedure on hypersensitivity reaction | minutes, during surgery | 
| Influence of age on hypersensitivity reaction | See if there is a link or influence of age on hypersensitivity reaction | minutes, during surgery | 
| Influence of weight on hypersensitivity reaction | See if there is a link or influence of weight on hypersensitivity reaction | minutes, during surgery | 
| Influence of height on hypersensitivity reaction | See if there is a link or influence of height on hypersensitivity reaction | minutes, during surgery | 
| Influence of the experience of the gastroenterologist on hypersensitivity reaction | See if there is a link or influence of experience of gastroenterologist on hypersensitivity reaction | minutes, during surgery | 
| Influence of a respiratory comorbitidity on hypersensitivity reaction | See if there is a link or influence of respiratory comorbidity on hypersensitivity reaction. | minutes, during surgery | 
| Influence of a neurological comorbidity on hypersensitivity reaction | See if there is a link or influence of a neurological comorbidity on hypersensitivity reaction | minutes, during surgery | 
| Influence of reason for investigation on hypersensitivity reaction | See if there is a link or influence of the reason for investigation on hypersensitivity reaction | minutes, during surgery | 
| Influence of a respiratory infection on hypersensitivity reaction | See if there is a link or influence of a respiratory infection on hypersensitivity reaction. | minutes, during surgery | 
| Influence of GERD on hypersensitivity reaction | See if there is a link or influence of GERD on hypersensitivity reaction | minutes, during surgery | 
| Influence of an allergy besides egg or soy on hypersensitivity reaction | See if there is a link or influence of another allergy besides egg or soy on hypersensitivity reaction. | minutes, during surgery | 
| Influence of ketamine on hypersensitivity reaction | See if there is a link or influence of ketamine on hypersensitivity reaction. | minutes, during surgery | 
| Influence of midazolam on hypersensitivity reaction | See if there is a link or influence of midazolam on hypersensitivity. | minutes, during surgery |