Hypersensitivity Reactions to Propofol in Children

NCT04839666 | Completed

• 1 other identifier: 2021-
• Study Type: observational
• Target: 2,299
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Influence of gender on hypersensitivity reaction

  minutes, during surgery

• Influence of ASA on hypersensitivity reaction

  minutes, during surgery

• Influence of type of procedure on hypersensitivity reaction

  minutes, during surgery

• Influence of age on hypersensitivity reaction

  minutes, during surgery

• Influence of weight on hypersensitivity reaction

  minutes, during surgery

Study Arms (1)

Propofol

Drug: Propofol

Interventions

Propofol DRUG

Perioperatively propofol administration

Propofol

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Procedure without administration of propofol

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Hypersensitivity; Egg Hypersensitivity

Interventions

Propofol

Condition Hierarchy (Ancestors)

Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 9, 2021
• Study Start: January 1, 2010
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)