Delhi Hospital and a doctor asked to pay Rs. 20 lakh as compensation due to intra-arterial phenargan

Intra-arterial phenargan is a known complication in 2 in 57575 cases

 

In a 2001 case, Delhis 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 injection.

The information contained in the package insert should have been cited as a defence. 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.

Let’s take a look at what literature has to say about promethazine.

 

Promethazine (Phenergan) injection is a commonly used product that possesses antihistamine, sedative, anti-motion sickness, and antiemetic effects. It 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 parenteral 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 re-examine 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.

Here is how one can use IV promethazine.

  • Since 25 mg/mL is the highest concentration of promethazine that can be given IV, stock only this concentration (not the 50 mg/mL concentration).
  • Consider 6.25 to 12.5 mg of promethazine as the starting IV dose, especially for elderly patients.
  • Dilute the drug in 10 to 20 mL of normal saline if it will be administered via a running IV, or prepare the medication in mini bags containing normal saline. Extravasation can also be recognized more quickly when promethazine is diluted than if the drug is given in a smaller volume.
  • Give the medication only through a large-bore vein (preferably via a central venous access site, but absolutely no hand or wrist veins). Check patency of the access site before administration. Note: 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. Use of syringes with rigid plungers or small bore needles might obscure typical arterial backflow if this is relied upon alone.
  • Administer IV promethazine through a running IV line at the port furthest from the patient’s vein.
  • Administer IV promethazine over 10-15 minutes.
  • Before administration of the drug, tell the patient to let you know immediately if burning or pain occurs during or after the injection.
  • Take consent
  • Build an alert that the drug is a vesicant and should be diluted and administered slowly through a running IV.
  • Consider safer alternatives like ondansetron

There have been some published cases of intra-arterial injection of promethazine.

  • Necrosis caused by intra-arterial injection of promethazine: case report: Promethazine injections have led to necrosis and gangrene of the distal upper extremity when inadvertently injected into an artery. There have been few case reports of this alarming complication in the literature. We report on 2 cases of intra-arterial promethazine injection that led to amputation (Foret AL, et al. J Hand Surg Am. 2009 May-Jun;34(5):919-23).
  • Accidental intra-arterial injection of promethazine HCI during general anesthesia: Report of a case (Mostafavi H. Anesthesiology.1971;35:645).
  • Accidental intra-arterial injection: A case report, new treatment modalities, and a review of the literature (Keene JR, et al. J Oral Maxillofac Surg. 2006;64(6):965-8).
  • An unusual adverse event with the use of intravenous bolus of promethazine (Phenergan): The earlier used sedatives like promethazine, pethidine and pentazocine (Fortwin) are not commonly used these days but at times they are used especially in periphery for postoperative sedation and in gynecological surgeries and wards. We hereby report an unusual adverse event associated with the use of intravenous bolus of promethazine. With this case report we want to highlight that if promethazine is to be used for any purpose it should be given preferably intramuscular and if given intravenously, should be diluted and given slowly in a good running cannula. (However, patient inspite of receiving 20mg pethidine was anxious. For that 12.5mg of promethazine was given as slow IV push. Same dose of promethazine is repeated after 1hr intraoperatively. Rest of the intraoperative period was uneventful. No other drug was injected after promethazine. In the postoperative period, a bluish discoloration was noted on the dorsum of the hand in which the cannula was secured. And on touch the dorsum of the hand was cold). (Singh A, et al. Int J Res Med Sci. 2018 Jan;6(1):347-348).

The outcome of this judgement of the Delhi High Court could well be denial of injections in clinics. Doctors would stop administering injections in their clinics or nursing homes.

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