Emergency Medical Protocol for Management of Anaphylactic Reaction

Medications and supplies for assessing and managing anaphylaxis

A clinical provider with access to the emergency equipment should be immediately available to assess and
manage anaphylaxis

Should be available at all sites If feasible, include at sites (not required)

Epinephrine prefilled syringe or auto injector Pulse oximeter
H1 antihistamine (e.g., diphenhydramine) Oxygen
Blood pressure cuff Bronchodilator (e.g., albuterol)
Stethoscope H2 antihistamine (e.g., famotidine, cimetidine)
Timing device to assess pulse Intravenous fluids
Intubation kit
Adult-sized pocket mask with one-way valve (also
known as cardiopulmonary resuscitation (CPR)
mask)

Management of anaphylaxis at a COVID-19 vaccination site

Saudi MoH Protocol for Adult and Pediatric Management of Anaphylaxis
(Version 1.2) December 28th, 2020

Disclaimer: This is a living guidance that is subject to change as more evidence accumulates. It will be updated regularly and whenever
needed. The guidance should be used to assist healthcare practitioners select the best available management in case of anaphylaxis shock.

1. Introduction:

• Anaphylaxis is a serious systemic hypercreativity reaction that is usually rapid in onset and may cause death. Severe
anaphylaxis is characterized by potentially life-threatening compromise in airway, breathing and/or the circulation, and
may occur without typical skin features or circulatory shock being present. (World Health Organization International Classification
of Diseases 11th Edition)
• It is mandatory for healthcare providers to report all administration errors, all adverse events, cases of Multisystem
Inflammatory Syndrome (MIS), and hospitalized or fatal cases following medication administration to the Saudi Food
and Drug Authority (SFDA) via: https://ade.sfda.gov.sa/. Also record the allergy in the patient medical record and
system.
• It is mandatory that vaccination/medication administration sites are equipped with Cardiopulmonary Resuscitation
(CPR) carts and the availability of immediate treatment management and medications.

2. Diagnosis of Anaphylaxis:
By the existence of TWO of the followings:
1- Respiratory distress signs and symptoms including dyspnoea, wheeze, stridor, upper airway swelling (lip, tongue,
throat, uvula, or larynx), hoarse voice, tachypnoea, increased use of accessory respiratory muscles, cyanosis and/or
grunting.
2- Tachycardia, dizziness, syncope or hypotension
3- Gastrointestinal symptoms of vomiting, abdominal pain (cramps) and/or diarrhea.
4- Dermatological manifestations of generalized urticaria, erythema, pruritus or angioedema (angioedema can be
localized or generalized).

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 Note:

• The presence of angioedema alone should trigger the physician to administer Epinephrine irrespective of the
presence of other criteria
• The presence of hypotension without another explanation should trigger the physician to administer Epinephrine
irrespective of the presence of other criteria.

3. Management of Anaphylaxis:

3.1 Roles:

Onsite

3.1.1 Physician role: Upon immediate fulfilment of anaphylaxis definition follow the anaphylaxis management
protocol below.

3.1.2 EMS role: An EMS personal shall be ready for immediate transfer of the patient and shall notify the
dispatch center about the case before arrival. An EMS personal should carry two doses of 0.5 mg of Epinephrine
(1:1000 concentration) loaded in the syringe and ready to be given upon any signs of deterioration while in
route. This includes an increase in dyspnea, drop in blood pressure or depressed in the level of consciousness, or
angioedema. The EMS shall endorse the case to the ER physician.

Hospital

3.1.3 Triage Role:

All labelled anaphylaxis from the field hospital should be put level II and receive a monitored bed in
critical care. The patient shall be assessed by the physician in the critical area and then upon his/her
discretion to be downgraded to non-monitored bed.

4.2.2 Physician role:

A complete assessment of the airway, breathing and circulation and any impeding issues.

1.2 Protocol:
o Appropriate medical treatment must be immediately available in the event an acute anaphylactic reaction occurs.
o Removal of the inciting cause, if possible (eg, stop infusion of a suspect medication).
1. Epinephrine (1 mg/mL preparation) is the first option in the management of anaphylaxis.
• Adults: Give 0.3 to 0.5 mg intramuscularly (IM) in the mid-outer thigh and can be repeated every 5 to 15 minutes as
needed.
• Pediatric:
• Infant under 10 Kg: 0.01 mg/kg IM in the mid-outer thigh can be repeated every 5 to 15 minutes as
needed.
• 10 – 25 Kg: 0.15 mg IM in the mid-outer thigh can be repeated every 5 to 15 minutes as needed.
• >25 – 50 Kg: 0.3 mg IM in the mid-outer thigh can be repeated every 5 to 15 minutes as needed.
• 50 kg, maximum is 0.5 mg per dose IM in the mid-outer thigh can be repeated every 5 to 15 minutes as
needed.
2. If evidence of impending airway obstruction form angioedema, immediate intubation should take place by the most
available expert to avoid airway trauma.
3. Place patient in recumbent position, if tolerated and elevate lower extremities.
4. Give 8 to 10 L/minute oxygen via facemask or up to 100% oxygen, as needed.
5. Treat hypotension with rapid infusion:

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 • Adult: 1 to 2 liters intravenous (IV) normal saline, repeat as needed.
• Pediatric: 20 mL/kg IV normal saline. Re-evaluate and repeat fluid boluses (20 mL/kg), as needed.

6. For bronchospasm resistant to IM epinephrine, give Albuterol (salbutamol)

• Adult: 2.5 to 5 mg of in 3 mL saline via nebulizer, or 2 to 3 puffs by metered dose inhaler. Repeat, as needed.
• Pediatric: 0.15 mg/kg (minimum dose: 2.5 mg) in 3 mL saline inhaled via nebulizer. Repeat, as needed.

Adjunctive Therapies of Anaphylaxis:

o Continuous noninvasive hemodynamic monitoring and pulse oximetry monitoring should be performed.
o Urine output should be monitored in patients receiving IV fluid resuscitation for sever hypotension or shock.
o For reliving urticaria and itching, consider giving cetirizine:
• Adult: 10 mg IV (given over 2 minutes)
• Pediatric:
• 6 months – 5 years: 2.5 mg IV (given over 2 minutes).
• 6 – 11 years: 5 – 10 mg IV (given over 2 minutes).
OR diphenhydramine:
• Adult: 25 to 50 mg IV (given over 5 minutes).
• Pediatric: 1 mg/kg (max 40 mg IV, over 5 minutes).
o Consider giving famotidine:
• Adult: 20 mg IV (given over 2 minutes).
• Pediatric: 0.25 mg/kg (max 20 mg IV, over at least 2 minutes).

o Consider giving methylprednisolone:

• Adult: 125 mg IV.
• Pediatric: 1 mg/kg (max 125 mg) IV.

Treatment of refractory symptoms of Allergic Reactions:

o All patients on epinephrine require continuous noninvasive monitoring of blood pressure, heart rate and function,
and oxygen saturation.
o For patients with inadequate response to IM epinephrine and IV saline, consider epinephrine infusion:
• Adult: beginning at 0.1 mcg/kg/minute by infusion pump. Titrate the dose continuously according to blood
pressure, cardiac rate and function, and oxygenation.
• Pediatric: 0.1 to 1 mcg/kg/minute. Titrate the dose continuously according to blood pressure, cardiac rate and
function, and oxygenation.
o Some patients may require norepinephrine or dopamine should be given by infusion pump, with the dose titrated
continuously according to blood pressure and cardiac rate/function and oxygenation.
o Patients on beta-blockers, give glucagon for adult patients 1 to 5 mg IV over 5 minutes, followed by infusion of 5 to 15
mcg/minute. (rapid administration may cause vomiting). Need to hold beta-blockers.
o Consider Racemic Epinephrine or L-Epinephrine nebuliser solution, dose of 0.5 mL of 2.25% solution in 2.5 mL of
normal saline.
o Consider Glucagon for those with refractory hypotension and on beta-blocker by giving 1 - 5 mg IV q5min then
infusion of 5 to 15 mcg/minute.
o Consider famotidine 20 mg IV administered over 2 minutes (H2 blocker).
o CTU should be informed about the case irrespective of the laboratory result for admission for observation

Minor allergic reaction

The definition of minor allergic reaction is any allergic reaction post vaccine that does not fulfil the definition of
anaphylaxis mentioned above. Provide the patient with Methylprednisolone 125 mg IV (or hydrocortisone 100 mg IV)
and Diphenhydramine 25 mg IV.
The decision to transfer the patient or keep the patient for observation under the emergency consultant's discretion.

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Patient counseling

o Patients who experience anaphylaxis after the first dose should be instructed not to receive additional doses.
o Patients should be referred to an allergist-immunologist for appropriate work-up and additional counseling.
o Home medications:
• Diphenhydramine
o Adult: 25 – 50 mg orally every 6- 8 hours for 2 days
o Pediatric:
▪ 2–6years: 6.25mg every 4–6 hours for 2days
▪ 6–12years: 12.5-25mg every 4–6 hours for 2days
• Epinephrine pen when needed

N.B
** If itching and swelling are confined to the injection site, observe the patient closely for the
development of generalized symptoms.
** Antihistamines (e.g., H1 or H2 antihistamines) and bronchodilators do not treat airway obstruction
or hypotension, and thus are not first-line treatments for anaphylaxis. However, they can help provide
relief for hives and itching (antihistamines) or symptoms of respiratory distress (bronchodilators) but
should only be administered after epinephrine in a patient with anaphylaxis. Because anaphylaxis may
recur after patients begin to recover, monitoring in a medical facility for several hours is advised, even
after complete resolution of symptoms and signs.
**Monitor the patient closely until EMS arrives. Perform CPR, if necessary, and maintain airway. Keep
the patient flat on back unless he or she is having breathing difficulty. If breathing is difficult, patient’s
head may be elevated, provided blood pressure is adequate to prevent loss of consciousness. If blood
pressure is low, elevate legs. Monitor blood pressure and pulse every five minutes.
**Record vital signs and medications administered to the patient, including the time, dosage,
response, and the name of the medical personnel who administered the medication, as well as other
relevant clinical information.
** Verbally brief the ambulance staff upon its arrival

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