Hypersensitivity Reactions to Propofol in Children

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

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.

Study Overview

• Status: Completed
• Conditions: Hypersensitivity; Allergy, Egg; Soy Allergy
• Intervention / Treatment: Drug: Propofol

• Study Type: Observational
• Enrollment (Actual): 2299

Contacts and Locations

Study Locations

• Belgium
  • Brussel
    • Jette, Brussel, Belgium, 1090
      • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 14 years (Child)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Propofol	Drug: Propofol; Perioperatively propofol administration

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: March 30, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 9, 2021

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Egg Hypersensitivity; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Hypnotics and Sedatives; Propofol
• Other Study ID Numbers: 2021-

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No