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Clinical Trials of Aeknil Injection by
Medical & Civil Hospital, Ahmedabad
 

 


To judge whether a drug is useful in a specific clinical setting, or when there is more than one drug available, to decide which is preferable requires information through laboratory data or data available through clinical studies. The knowledge about the action of a drug, its potency, its toxic effects obtained from the laboratory, is a usual initial clue to its therapeutic potentials and its dangers. 

Amongst the long list of antipyretics and analgesics, Para Aminophenol derivatives are very much in use with the Salicylates. One of the safest derivatives of Para Aminophenol group is C-Acetyl Para Amino Phenol (Paracetamol). It is recommended that Acetaminophen (Paracetamol) is the drug of choice when analgesic must be continued over a long period of time. N-Acetyl Para Aminophenol (Paracetamol) is available in the Oral (tablet and syrup) as well as the Injectable form. Any drug is preferably given by oral route especially in pediatric practice. However, on some occasions e.g., in hyperptrexia, unconscious patients where it is neither safe nor advisable to use any oral therapy, Injectable form is the only effective method to lower the pyrexia. Similarly, when quick analgesic is required one needs an Injectable form. The optimal dose recommended for Acetaminophen is 0.3 to 0.6 gms per dose, which is equivalent to most of the popular antipyretics and analgesics like Salicylates and other Para Aminophenol derivatives. As the drug is considered as a drug of choice when treatment is required for prolonged time, it is obvious that the toxic effects would be less. The toxicity is usually due to ingestion or administration of large amounts of the drug. The toxic effects include formation of methemoglobin and sulfhemoglobin, which give rise to cyanotic colour. Other symptoms encountered include dyspnea, vertigo, weakness, anginal pain, vascular collapse and respiratory depression. Renal damage is not reported with Acetaminophen.

 

MATERIALS AND METHODS 

N-Acetyl Para Aminophenol (Paracetamol) was used in the Injectable form mainly to note its antipyretic effects. In small children, it is very difficult to assess the analgesic effect and hence no attampt is made to note the analgesic effect. Secondly, the time required to reduce the pyrexia was noted. If the pyrexia recurred, the interval was noted, and lastly, any untoward effects were observed and recorded. Any child in the pediatric ward with temperature above 101°F was taken for study. The cases were alternately given Injection of Analgin or if pyrexia recurred he was given the two antipyretics alternately. 

The dose of N-Acetyl Para Aminophenol (Paracetamol) is 0.3 to 0.6 gm/dose. In children the usual practice is to give 60-mgm per each year of age till the maximum is reached. Injection N-Acetyl Para Aminophenol (Paracetamol) contains 150 mg/ml. The drug was used in the following schedule:

¼ ml/dose up to 1 year of age

½ ml/dose from 1 to 2 year of age

1 ml. dose for 3 to 4 years of age

2 ml. dose above 10 years of age

 

Immediately before and after the Injection was given the temperature of the patient was recorded both per rectum and in the axilla for 2 minutes with standardised thermometers. The temperature was recorded every half-hour, till the temperature came to below 98F for at least 4 hours. Any side effects like appearance of cyanosis, dyspnoea, weakness or signs of vascular and respiratory collapse were watched for and recorded if necessary.

 

The results were graded as follows: 

GOOD If the temperature touched normal within ½ hour.
FAIR If the temperature was normal within 2 hours.
POOR If no response till 2 hours.


 

 
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