Antidotes |
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Prescription of methylene blue |
Methemoglobinemia due to inhaled nitric oxide, use of local anesthetics lidocaine and benzocaine |
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Prescription of antihistamine |
Hypersensitivity |
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Prescription of flumazenil |
Over-sedation from benzodiazepines |
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Prescription of levothyroxine after use of: dopamine/dobutamine /amiodarone/phenytoin |
Drug-induced hypothyroidism |
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Prescription of methadone/lorazepam |
Treatment of withdrawal syndrome from opioids and/or hypnotic-sedative drugs |
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Prescription of naloxone |
Over-sedation, thoracic rigidity due to opioid products |
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Prescription of neostigmine |
Residual blockade/respiratory arrest following use of neuromuscular junction blockers |
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Clinical |
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Increased frequency of bowel movements |
Diarrhea, intolerance to medications |
Consider newborn’s habitual frequency of bowel movements and then determine increase in frequency and occurrence of suspected adverse drug events. Requires daily recordings of number of newborn’s bowel movements. |
Necrotizing enterocolitis |
Following use of non-steroidal anti-inflamamatory drug; caffeine; ranitidine |
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Erythema/Urticaria/Papule/ Rash |
Hypersensitivity reactions |
Consider these words as trigger when recorded in the clinical assessments on patient record and not related to diaper rash or neonatal toxic erythema, a benign self-limited condition 2727. Araújo T, Schachner L. Erupções vesicopustulosas benignas no neonato. An Bras Dermatol 2006; 81:359-66.. |
Mechanical stimulation to pass stools /Use of glycerin suppository |
Intestinal constipation |
Especially used to detect intestinal constipation after use of known constipating drugs like opioid products. The list of triggers for older children recommends prescription of laxatives or use of stool softeners 8, which are not prescribed for newborns. |
Rise in arterial pressure |
Arterial hypertension |
Consider rise in systolic and/or diastolic arterial pressure above the 95th percentile for gestational age, birth weight, and corrected age. Also consider when the expressions “elevated blood pressure” or “increased blood pressure” are recorded on patient chart. |
Hypotension |
Drop in arterial pressure; hypersensitivity reactions; over-sedation |
After 48 hours of life, consider when mean arterial pressure ≤ 30mmHg. Also consider when the expressions “hypotensive” and “drop in blood pressure” are recorded on patient chart. |
Unplanned intubation |
Over-sedation, hypersensitivity reactions |
Can also be identified with the expressions: “intubation” or “OTI performed” (orotracheal intubation). |
Cardiorespiratory arrest/Cardioversion |
Over-sedation, hypersensitivity reactions |
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Pneumonia |
Associated with previous use of ranitidine |
Ranitidine-induced hypochloridria can alter intestinal microbiota, contributing to increased susceptibility to infections. |
Hearing impairment |
Due to use of ototoxic drugs |
For example, gentamicin, amikacin, and loop diuretics. |
Prescription of phenobarbital |
Seizures induced by drugs acting on the central nervous system or that alter the fluid-electrolyte balance |
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Blood in feces/“Dark brown” vomit |
Gastrointestinal bleeding, hemorrhage |
Consider starting at 72 hours after birth, since the newborn may have swallowed maternal blood during birth. |
Drop in oxygen saturation |
Due to use of anticonvulsants, hypnotics, sedatives, surfactant |
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Vomiting |
Vomiting, intolerance to medications |
Use instead of the trigger “prescription of antiemetics”, which is on the list of pediatric triggers applied to older children to identify nausea and vomiting 8, since antiemetics are not used in newborns. |
Oversedation |
Due to hypnotics-sedatives, opioid products |
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Medications stop |
May point to the drug suspected of causing the adverse event |
Also consider when the word “suspend” is next to a previously prescribed drug. Not considered as a trigger when referring to termination of treatment or dose adjustment. |
Tachycardia |
Due to use of adrenergic agonists, caffeine |
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Transferred to a unit with more intensive care |
May indicate that a serious adverse occurred, requiring patient’s transferal to a unit with more intensive therapy to provide adequate support for treatment of this adverse drug events. |
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Laboratory |
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Anemia |
hemorrhage, use ofnon-steroidal anti-inflammatory drug |
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Increase in serum creatinine |
Worsening of renal function due to nephrotoxic drugs vancomycin, aminoglycosides, loop diuretics |
Consider trigger if not dehydration in the patient. Consider increase in serum creatinine > 0.2-0.3mg/dL/day or > 1.0mg/dL. Also consider if this expression is recorded on patient chart. |
Increase in serum urea |
Worsening of renal function due to nephrotoxic drugs vancomycin, aminoglycosides, loop diuretics |
Consider trigger when not patient dehydration. Consider values > 25mg/dL. Also consider if this expression is recorded on patient chart |
Increase in hepatic enzymes AST/ALT |
Worsening of hepatic function due to use of hepatotoxic drugs |
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Eosinophilia |
Hypersensitivity reactions |
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Hypercalcemia; hypocalcemia; hypernatremia; hyponatremia; hyperphosphatemia; hypophosphatemia; hyperkalemia; hypokalemia; hypermagnesemia; hypomagnesemia |
Fluid-electrolyte imbalance common to various drugs |
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Hyperglycemia; hypoglycemia |
Drugs that alter carbohydrate metabolism and/or insulin secretion |
Hyperglycemia: consider trigger when blood glucose > 125mg/dL and/or when “hyperglycemia” recorded on patient chart. Hypoglycemia: Consider more than 72 hours after birth, since newborns have a lower hepatic glucose reserve and high risk of development of hypoglycemia soon after birth. Consider trigger when blood glucose < 40mg/dL and/or when “hypoglycemia” recorded on patient chart. |
Leukocytosis; leukopenia; neutrophilia; neutropenia; thrombocytosis; thrombocytopenia |
Drug-induced hematologic or bone marrow alterations |
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