Allergy DrugNCT05670756
Preoperative Survey to Evaluate Patient Allergy
An observational study of Allergy Drug and Allergic Reaction, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making… Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Allergy Drug, Allergic Reaction, Pediatric
- What is being tested?
- Survey
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2023to 13 Nov 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients presenting for surgery at a children's hospital.
Who may be able to join
- Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia
Who cannot join
- Patients who are not able cognitively to complete the computerized survey due to physical or intellectual impairment or communication issues related to non-English speaking patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
Official title: Preoperative Survey to Evaluate Patient Allergy List, Type of Response to Listed Medication, and Its Relevance to Perioperative Care
The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.
- Conditions
- Allergy Drug, Allergic Reaction, Pediatric, Surgery
- Being tested
- Survey
- Medical subject headings
- Drug Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.
| Study group | Role | What they receive |
|---|---|---|
| Medication allergy | Patients who have a medication allergy listed in their electronic medical record. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
True Allergy (Consistent With an IgE-mediated Reaction)
Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose
Measured: Baseline
Secondary outcomes (2)
Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction)
Cutaneous reactions (rash, skin redness) longer than 6 h after the dose
Measured: Baseline
Not True Allergy (Not Related to IgE-mediated Reaction)
Allergy listed in the medical record but instead: Recognized adverse effect of the medication, Family history of allergy, Based on medical history or other reasons, or Parents reported their child has no allergy
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 May 2023
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Allergy DrugStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670756
- Sponsor's protocol ID
- STUDY00002974
- Status last verified
- Oct 2024
- First submitted
- 20 Dec 2022
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Survey to Evaluate Patient Allergy List, Type of Response to Listed Medication, and Its Relevance to Perioperative Care
- ClinicalTrials.gov ID
- NCT05670756
- Acronym / sponsor ID
- STUDY00002974
- Conditions
- Allergy Drug, Allergic Reaction, Pediatric, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will only involve identification of the listed allergies from the electronic medical record and investigation into the symptoms that prompted this allergy listing. The purpose is to evaluate demographics and prevalence of allergies in patients presenting for surgery, evaluate the medical decision making process behind allergy identification, and determine its potential impact on perioperative care. The participants will be asked to complete a survey in REDCap using an iPad during the visit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication allergy | – | Other: SurveyPatients who have a medication allergy listed in their electronic medical record. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients presenting for surgery at a children's hospital.
Key inclusion criteria (1 listed)
- Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia
Key exclusion criteria (1 listed)
- Patients who are not able cognitively to complete the computerized survey due to physical or intellectual impairment or communication issues related to non-English speaking patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyParents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy. | Other | Medication allergy |
Primary outcome
True Allergy (Consistent With an IgE-mediated Reaction)
Time frame: Baseline
Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose
2 secondary outcomes
Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction)
Time frame: Baseline
Not True Allergy (Not Related to IgE-mediated Reaction)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy Drug and Allergic Reaction, run by Nationwide Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
True Allergy (Consistent With an IgE-mediated Reaction) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.