Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05706246 |
| Other study ID # |
HIPOP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 30, 2020 |
| Est. completion date |
June 28, 2022 |
Study information
| Verified date |
January 2023 |
| Source |
Istanbul University - Cerrahpasa (IUC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There are limited studies on perioperative hypersensitivity (POH) reactions in children. The
diagnosis of POH might be underestimated due to the difficulty of recognizing the reactions.
Anaphylaxis may go unnoticed due to the unconscious state of the patient. Urticaria may be
overlooked due to the sterile covers. This study aimed to evaluate POH reactions
prospectively.
Description:
Patients with intraoperative signs of diffuse erythema, urticaria, angioedema, sudden
hypotension, tachycardia, bradycardia, arrhythmia, bronchospasm, vomiting, difficulty in
ventilation, and end-tidal carbon dioxide (CO2) increase were included in the study.
Reactions were graded from I to IV depending on increasing severity (Grade I, presence of
cutaneous signs; Grade II, presence of measurable but non-life-threatening symptoms,
including cutaneous effects, arterial hypotension, cough, or difficulty in mechanical
ventilation; Grade III, presence of life-threatening reactions: cardiovascular arrest,
tachycardia or bradycardia, arrhythmias, severe bronchospasm; Grade IV, circulatory
inefficacy, cardiac and/or respiratory arrest).
In case of suspicious findings in terms of hypersensitivity reactions during surgery or
recovery from anesthesia; the basal serum tryptase level was recorded at the time of the
reaction, 2 hours after the reaction, and any time after 24 hours.
The severity of the reaction, vital signs, treatments applied, and medications administered
after the reaction were recorded in the pre-prepared follow-up form. Then, skin tests were
performed with all exposure agents,latex and chlorhexidine 4-6 weeks after the reaction in
accordance with the records kept by the Pediatric Allergy and Immunology Clinic. A wheal
diameter of at least 3mm larger than negative control is regarded a positive skin prick test,
while in intradermal testing (IDT), a diameter 3 mm larger than the intracutaneously
administered depot of the drug solution following 15-20 min is considered positive. Histamine
was used as a positive control, and saline as a negative control. For positive skin test
cases, basophil activation test was performed with the available drug. Skin prick and
intradermal test concentrations were applied according to the recommendations for
non-irritant test concentrations published by the European Network for Drug Allergy (ENDA)
(8). Specific immunoglobulin E (spIgE) measurements were performed for latex and
chlorhexidine on skin test positive cases, and for penicillin before the skin test for one
case that experienced anaphylaxis due to antibiotics. The methodology used was ImmunoCAP®
(Thermo Fisher Scientific, Uppsala, Sweden). Serum total tryptase levels were measured with
ImmunoCAP® (Thermo Fisher Scientific). The increased serum tryptase value was calculated with
the following formula: >1.2*basal tryptase level +2 mcg/L. In suspicious cases where the
latex skin test was not clinically compatible, cutaneous provocation with latex was
performed. Comparisons were made with the basophil activation test for positive results in
drug skin tests.
