Hypersensitivity Reactions to Propofol in Children

NCT ID: NCT04839666

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2299 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-01
• Study Completion Date: 2016-08-31

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.

Conditions

Hypersensitivity; Allergy, Egg; Soy Allergy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Propofol

Propofol

Intervention Type: DRUG

Perioperatively propofol administration

Interventions

Propofol

Perioperatively propofol administration

Intervention Type: DRUG

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

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

UZ Brussel

Jette, Brussels Capital, Belgium

Countries

Belgium

Other Identifiers

2021-

Identifier Type: -

Identifier Source: org_study_id