Evaluating Sucrose and Cold Oral Interventions for the Treatment of Oral Pruritus During Allergy Procedures. (FROST)
A Randomized Controlled 2×2 Factorial Study Evaluating Sucrose and Cold for the Treatment of Oral Pruritus During Allergy Procedures
This is a two-center, randomized, open-label, factorial controlled trial. This trial aims to evaluate the efficacy of exposure to sucrose and ice, alone and in combination, compared to control, in reducing oral pruritus during allergy procedures.
The population will include patients aged 8 years and older presenting with oral pruritus in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Clinically significant oral pruritus will be defined as a pruritus intensity of ≥3/10 on the ICH NRS, and a symptom bothersome enough that the patient would normally seek treatment.
Eligible participants will be randomized to one of four groups (1:1:1:1 ratio):
- Sucrose only (3.5 g granulated sugar)
- Cold only (20 mL of ice in the form of popsicle)
- Sucrose + cold (20 mL frozen sucrose solution)
- Control (20 mL room-temperature water)
Participants will be asked to report when the pruritus has decreased to a level at which they would not normally seek treatment, as well as when it has completely resolved.
The evolution of oral pruritus will be assessed using an 11-point Numeric Rating Scale (ICH NRS). Pruritus intensity will be measured every 30 seconds during the first 5 minutes after administration of the study intervention and then every 1 minute until 15 minutes post-intervention.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ginevra Lacatusu
- 전화번호: 2670 514-345-4931
- 이메일: ginevra.lacatusu.hsj@ssss.gouv.qc.ca
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H2X 0C1
- CHUM
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연락하다:
- Philippe Bégin
- 전화번호: 2668 514-345-4931
- 이메일: philippe.begin.med@ssss.gouv.qc.ca
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Montreal, Quebec, 캐나다, H3T1C5
- Chu Sainte-Justine
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연락하다:
- Maitena montuzet
- 전화번호: 117375 514-345-4931
- 이메일: maitena.montuzet.hsj@ssss.gouv.qc.ca
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Aged 8 years and older.
- Have a clinically diagnosed IgE-mediated food allergy, supported by a compatible clinical history and evidence of IgE sensitization (e.g., skin prick testing and/or serum food-specific IgE), as determined by the treating allergist.
- Undergoing an oral food challenge or initiating oral immunotherapy / undergoing an oral immunotherapy dose escalation.
- Develop oral pruritus following allergen administration with a minimum score of 3/10 on the ICH Numeric Rating Scale (ICH NRS).
- Be able to assess and report their symptoms using the ICH NRS.
- Provide informed consent to participate in the study (and assent, where applicable, in accordance with local regulations).
Exclusion Criteria:
- Any oral condition or pathology that could interfere with the perception, assessment, or interpretation of oral pruritus symptoms.
- Presence or development of systemic allergic symptoms for which epinephrine administration would be clinically indicated.
- Poorly controlled diabetes mellitus, as defined by the treating physician.
- Any condition affecting oral sensation or the ability to accurately communicate symptoms using the ICH NRS.
- Cold urticaria or significant hypersensitivity to cold.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 요인 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Sucrose only
3.5 g granulated sugar |
Sucrose only (3.5 g granulated sugar) |
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활성 비교기: Cold only
20 mL of ice in the form of popsicle |
Cold only (20 mL of ice in the form of popsicle) |
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활성 비교기: Sucrose and cold
20 mL frozen sucrose solution |
Sucrose + cold (20 mL frozen sucrose solution) |
|
위약 비교기: Water
20 mL room-temperature water |
20 mL room-temperature water |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Area under the curve (AUC) of ICH NRS scores
기간: From baseline (pre-intervention) through 15 minutes post-intervention.
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Pruritus intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 (no itch) to 10 (worst imaginable itch). Higher scores indicate greater pruritus intensity and therefore a worse outcome. |
From baseline (pre-intervention) through 15 minutes post-intervention.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to reduction of at least 2 points from the baseline ICH NRS score.
기간: From baseline (pre-intervention) through 15 minutes post-intervention.
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A reduction of at least 2 points on the 11-point Numerical Rating Scale (0-10) indicates an improvement in pruritus intensity. |
From baseline (pre-intervention) through 15 minutes post-intervention.
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Time to complete resolution of oral pruritus (ICH NRS score of 0).
기간: From baseline (pre-intervention) through 15 minutes post-intervention.
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Complete resolution of oral pruritus is defined as an Intra-episode Clinical Numerical Rating Scale (ICH NRS) score of 0, corresponding to no itching. The scale ranges from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus severity and therefore a worse outcome. |
From baseline (pre-intervention) through 15 minutes post-intervention.
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Time to a decrease in oral pruritus intensity to a level at which the participant would normally not seek treatment.
기간: From baseline (pre-intervention) through 15 minutes post-intervention.
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Time from intervention administration to the first assessment at which oral pruritus intensity decreases to a level that the participant reports would not normally prompt them to seek treatment. Pruritus intensity is assessed using the Intra-episode Clinical Numerical Rating Scale (ICH NRS), ranging from 0 (no itch) to 10 (worst imaginable itch), with higher scores indicating greater pruritus intensity and a worse outcome. |
From baseline (pre-intervention) through 15 minutes post-intervention.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MP-21-2027-10364
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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