Allergic Reaction, Allergy Drug, Pediatric, Surgery
Conditions
Brief 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 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.
Interventions
OTHERSurvey
Parents/guardians will complete a survey about when the medication allergy was identified and the exact symptomatology that resulted in determination of the allergy.
Sponsors
Nationwide Children's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
Inclusion criteria
* Patients 0-21 years of age presenting for surgery or procedure requiring anesthesia
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| True Allergy (Consistent With an IgE-mediated Reaction) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction) | Baseline | Cutaneous reactions (rash, skin redness) longer than 6 h after the dose |
| Not True Allergy (Not Related to IgE-mediated Reaction) | Baseline | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 250 |
| Total | 250 |
Baseline characteristics
| Characteristic | Medication Allergy |
|---|---|
| Age, Categorical <=18 years | 250 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 9 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 244 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 219 Participants |
| Region of Enrollment United States | 250 participants |
| Sex: Female, Male Female | 132 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 250 |
| other Total, other adverse events | 0 / 250 |
| serious Total, serious adverse events | 0 / 250 |
Outcome results
Primary
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
Time frame: Baseline
Population: In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication Allergies | True Allergy (Consistent With an IgE-mediated Reaction) | 135 Allergies |
Secondary
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
Time frame: Baseline
Population: In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication Allergies | Not True Allergy (Not Related to IgE-mediated Reaction) | 93 Allergies |
Secondary
Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction)
Cutaneous reactions (rash, skin redness) longer than 6 h after the dose
Time frame: Baseline
Population: In the 250 participants, there were at total of 301 medication allergies reported due to some participants being allergic to multiple medications.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Medication Allergies | Unlikely True Allergy (Less Relevant With an IgE-mediated Reaction) | 73 Allergies |