Dr K K Aggarwal
In a 2001 case Delhi’s Vimhans Hospital and a doctor have been asked to pay Rs. 20 lakh as compensation on grounds of treatment offered to a 12-year-old boy which led to the amputation of four fingers of his right hand on grounds of giving an intra-arterial injection of phenargan instead of an intravenous one.
What should have been the argument
According to the package insert, aspiration of dark blood does not preclude intra-arterial placement of the needle because blood can become discolored upon contact with promethazine.
Review of literature
Promethazine (PHENERGAN) injection is a commonly used product that possesses antihistamine, sedative, anti-motion sickness, and antiemetic effects. The drug is also a known vesicant which is highly caustic to the intima of blood vessels and surrounding tissue.
Formulated with phenol, promethazine has a pH between 4 and 5.5. Although deep intramuscular injection into a large muscle is the preferred par-enteral route of administration, product labeling states that the drug may be given by slow IV push, which is how it is typically given in most hospitals.
However, due to the frequency of severe, tragic, local injuries after infiltration or inadvertent intra-arterial injection, Institute of Safe Medical Practices recommends that the FDA reexamine the product labeling and consider eliminating the IV route of administration.
Severe tissue damage can occur regardless of the route of parenteral administration, although intravenous and inadvertent intra-arterial or subcutaneous administration results in more significant complications, including: burning, erythema, pain, swelling, severe spasm of vessels, thrombophlebitis, venous thrombosis, phlebitis, nerve damage, paralysis, abscess, tissue necrosis, and gangrene. Sometimes surgical intervention has been required, including fasciotomy, skin graft, and even amputation.
The true extent of this problem may be unknown. However, scores of reports suggest that patient harm may be occurring more frequently than recognized.
According to the package insert, “Proper IV administration of this product is well tolerated, but use of this route is not without some hazards.” To reduce the risk of these hazards, manufacturer labeling recommends to: give the drug in concentrations no greater than 25 mg/mL; administer the drug at a rate no greater than 25 mg/minute; inject the drug through the tubing of an infusion set that is running and known to be functioning satisfactorily; and to stop the injection immediately if the patient reports burning to evaluate possible arterial placement or perivascular extravasation.
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