Clinical trial NCT04839666: Hypersensitivity Reactions to Propofol in Children
Official title: Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypersensitivity
Allergy, Egg
Soy Allergy
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 2299
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children who underwent a surgery in UZ Brussels between the period of 01 January 2010 until 31 August 2016.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with a hypersensitivity reaction
timeFrame: minutes, during surgery
Secondary outcomes:
measure: Influence of gender on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of ASA on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of type of procedure on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of age on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of weight on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of height on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of the experience of the gastroenterologist on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of a respiratory comorbitidity on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of a neurological comorbidity on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of reason for investigation on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of a respiratory infection on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of GERD on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of an allergy besides egg or soy on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of ketamine on hypersensitivity reaction
timeFrame: minutes, during surgery
measure: Influence of midazolam on hypersensitivity reaction
timeFrame: minutes, during surgery
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussel
Study officials:
References: