Hypersensitivity Reactions to Propofol in Children

Overview

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.

Full Title of Study: “Incidence of Perioperative Hypersensitivity Reactions to Propofol in Children Allergic to Egg and/or Soy”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: August 31, 2016

Interventions

  • Drug: Propofol
    • Perioperatively propofol administration

Arms, Groups and Cohorts

  • Propofol

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants with a hypersensitivity reaction
    • Time Frame: minutes, during surgery
    • clinical features suggesting a hypersensitivity reaction present during anaesthesia were cutaneous, respiratory or cardiovascular manifestations.

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Universitair Ziekenhuis Brussel
  • Provider of Information About this Clinical Study
    • Sponsor

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