Trial Outcomes & Findings for Preoperative Survey to Evaluate Patient Allergy (NCT NCT05670756)

NCT ID: NCT05670756

Last Updated: 2024-10-15

Results Overview

Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose

• Recruitment status: COMPLETED
• Target enrollment: 250 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-10-15

Participant Flow

Participant milestones

Measure	Medication Allergy Patients who have a medication allergy listed in their electronic medical record. Survey: Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.
Overall Study STARTED	250
Overall Study COMPLETED	250
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preoperative Survey to Evaluate Patient Allergy

Baseline characteristics by cohort

Measure	Medication Allergy n=250 Participants Patients who have a medication allergy listed in their electronic medical record. Survey: Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.
Age, Categorical <=18 years	250 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	9 years n=5 Participants
Sex: Female, Male Female	132 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	244 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants
Race (NIH/OMB) White	219 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	250 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications.

Cutaneous reactions (hives, urticarial, skin redness, rash) within 6 h of the dose or Anaphylaxis or anaphylactoid reaction within 6 h of the dose

Outcome measures

Measure	Medication Allergies n=301 Allergies Allergies to medications listed in the electronic medical record or reported by the parents in the survey.
True Allergy (Consistent With an IgE-mediated Reaction)	135 Allergies

SECONDARY outcome

Timeframe: Baseline

Population: In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications.

Cutaneous reactions (rash, skin redness) longer than 6 h after the dose

Outcome measures

Measure	Medication Allergies n=301 Allergies Allergies to medications listed in the electronic medical record or reported by the parents in the survey.
Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction)	73 Allergies

SECONDARY outcome

Timeframe: Baseline

Population: In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications.

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

Outcome measures

Measure	Medication Allergies n=301 Allergies Allergies to medications listed in the electronic medical record or reported by the parents in the survey.
Not True Allergy (Not Related to IgE-mediated Reaction)	93 Allergies

Adverse Events

Medication Allergy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joseph D. Tobias, MD

Nationwide Children's Hospital

Phone: 614-722-4200

Email: joseph.tobias@nationwidechildrens.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place