Pediatric Non-Steroidal Anti-Inflammatory Drugs (NSAID) Allergy Study
- Conditions
- NSAIDBiomarkersPhenotypingChildren
- Registration Number
- NCT07034066
- Lead Sponsor
- Fundació Sant Joan de Déu
- Brief Summary
Non-steroidal anti-inflammatory drugs (NSAIDs) are some of the most commonly used medications to treat pain and inflammation. Many are available over the counter and are frequently used in children to reduce fever and relieve pain. Hypersensitivity (HS) to NSAIDs affects an estimated 0.6% to 5.7% of the general population. These reactions can be caused by immune or non-immune mechanisms. In most cases, they fall into two categories: reactions to a single NSAID or to several different NSAIDs.
Currently, the main way to diagnose NSAID hypersensitivity is through a drug provocation test (DPT)-this involves giving the patient the suspected drug under medical supervision to check for a reaction. It's considered the most reliable method. However, diagnosing these reactions in children can be challenging. Symptoms can vary widely, and there are few accurate alternative tests available to replace the DPT.
This study looks for easier ways-like symptoms or lab tests-to diagnose NSAID reactions, so fewer patients need to go through multiple DPT.
- Detailed Description
Hypersensitivity reactions (HSR) to NSAID in children, although similar to those in adults, present unique challenges in terms of diagnosis and management. While international classification systems are useful, real-world clinical scenarios often fall outside established criteria. Examples include:
* Multiple NSAID HSR involving both cutaneous and respiratory symptoms.
* NSAID-induced anaphylaxis dependent on food intake.
* Immediate selective reactions to more than one NSAID. These scenarios are frequently observed in pediatric patients, highlighting the need for a regional study to evaluate and properly address them.
This is a single-center, ambispective observational study.
Primary Objective:
To describe the clinical characteristics of children with NSAID hypersensitivity.
Secondary Objectives:
1. To describe the different clinical phenotypes and assess age-related differences.
2. To assess tolerance to alternative NSAIDs in patients with confirmed hypersensitivity.
3. To evaluate the usefulness of in vivo and in vitro tests in the diagnostic process.
4. To disseminate study findings.
The study design is based on 2 components:
* Retrospective Component: include participants diagnosed with NSAID HSR, who underwent DPT in the Pediatric Allergy Department at Hospital Sant Joan de Déu between January 2014 and December 2021. Data will be pseudonymized. A waiver of informed consent will be requested due to the long study period, the absence of risk, and the fact that many patients are no longer under follow-up.
* Prospective Component: participants with suspected NSAID HSR were included. Participants will be assessed during outpatient visits, where the following steps will occur:
* In vivo testing, where appropriate, using validated prick and intradermal techniques for paracetamol and metamizole. Controls will include saline (negative) and histamine (positive).
* A DPT will be performed with the suspected medication and/or suitable alternatives, in accordance with standard clinical practice.
* Nasal DPT using a rhinomanometer for patients suspected of NSAID-exacerbated respiratory disease (NERD).
* Families will be informed about the procedures, and informed consent will be obtained.
On the day of the DPT, a blood test (including total IgE, IgG, IgA, IgM, tryptase, IL-6) and urine sample (uLTE4 levels) will be collected.
If the DPT is positive, a second round of blood and urine samples will be collected.
The NSAID to be used in testing are commonly prescribed in pediatric practice and grouped by chemical structure:
Salicylic acid derivatives: Aspirin Para-aminophenol derivatives: Paracetamol (acetaminophen) Propionic acid derivatives: Ibuprofen, naproxen Acetic acid derivatives: Diclofenac Enolic acid derivatives: Pyrazolones, oxicams Fenamates (fenamic acid derivatives) COX-2 inhibitors: Celecoxib
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 257
- Children aged 0-17 years
- Completed DPT with the suspected and/or alternative NSAID
- Patients who did not undergo or complete the DPT
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical characteristics of pediatric patients with NSAID hypersensitivity, based on historical data and development of a diagnostic protocol. Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months. In both the retrospective and prospective arm, the investigators reviewed the medical records of patients who completed DPT. Participant demographic data were reviewed, including age, sex, personal and family history of atopy, and the results of DPTs performed on suspected medications and alternatives if necessary.
Final phenotypes after DPT were:
* Cross-intolerance (CI)
* Selective hypersensitivity (SH)
- Secondary Outcome Measures
Name Time Method Differences in clinical features across different pediatric age groups. Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months. In both the retrospective and prospective groups, factors that may predispose to having a confirmed HS based on the clinical history will be analyzed: sex, age, history of atopy, angioedema, rash/urticaria, reason for which the drug is prescribed, having presented more than 1 reaction with the same drug or different NSAIDs.
Rate of tolerance to alternative NSAIDs among patients with confirmed hypersensitivity. Retrospective arm: review of the medical records took about 4-6 months Prospective arm: from enrollment to DPT, 6-8 months. In the retrospective arm, in participants with cross-intolerance, all tolerated high-dose paracetamol and COX-2 inhibitors (meloxicam). Those with selective NSAID HS were tested for tolerance to alternatives from other groups as appropriate.
In the prospective arm, the investigators do not yet have results.Diagnostic performance of in vivo and in vitro tests. Prospective arm: from enrollment to DPT, 6-8 months. Both in vivo and in vitro testing were performed in the prospective arm, and DPT is still pending, so the investigators are waiting to complete this in order to analyze the results.
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Trial Locations
- Locations (1)
Hospital Sant Joan de Deu
🇪🇸Esplugues de Llobregat, Barcelona, Spain
Hospital Sant Joan de Deu🇪🇸Esplugues de Llobregat, Barcelona, Spain