Intra-arterial phenargan is a known complication in 2 in 57575 cases
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 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.
Dr KK Aggarwal
Padma Shri Awardee
Vice President CMAAO
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Immediate Past National President IMA
