Clinical Trials | AEKNIL™ (Paracetamol)

Clinical trials with AEKNIL

1. Effect of parenteral acetaminophen on the attenuation of post-operative pain subsequent colectomy. A randomized, double-blind clinical trial.
Eilyad Issabeagloo, Babak Abri Aghdam, Ali Rezaei, Department of Pharmacology, Islamic Azad University, Tabriza, Iran. Life Sci J 2013;10(4s):308-313
Abstract: Analgesic efficacy of parenteral acetaminophen is variable in different surgical procedures. Little data is available on its efficacy in colectomy. Intravenous Acetaminophen is a useful drug in treating postoperative pains and could be used alone or in combination with other drugs. Current study conducted this prospective, randomized, double blind study to evaluate and compare the efficacy acetaminophen (AEKNIL) with morphine in colectomy surgery over a 24 hour period. Methods: In a clinical trial, 79 patients candidate for elective lumbar colectomy were randomly put into groups receiving Acetaminophen (40 patients) or placebo (39 patients). In group one, 1 g I.V. Acetaminophen infusion was started 15 minutes before the end of surgery. Group 2 received 100 ml NaCl 0.9% in the same period. Pain scores were assessed at relaxation with VAS (visual analogue scale) at 0 (after awakening), 5, 10, 15 and 24 hours. Morphine use (according to patient's will due to pain) was recorded in 24 hours. Results: Acetaminophen group had significantly lower mean VAS (less severe pain) than placebo group after recovery (5.73±1.89 versus 6.85±2.11, p=0.004), 5 hours later (5.34±2.03 versus 7.67±1.9, p=0.01), 10 hours later (4.81±1.29 versus 5.71±1.31, p=0.02), 15 hours later (4.11±1.05 versus 4.67±1.61, p=0.02) and 24 hours later (2.61±1.31 versus 3.57±1.41, p=0.01). Morphine requirement in different periods was lower in Acetaminophen group than placebo which had no significant differences. Mean cumulative morphine use in 24 hours in Paracetamol group (5.89±2.79 mg) was lower than placebo group (8.48±3.51 mg), however the difference was not significant. Conclusion: Results of current study showed that intravenous Acetaminophen is effective in reducing postoperative pain severity, but does not reduce need for morphine use.

2. Analgesic efficacy of AEKNIL (Paracetamol) Injection in immediate post-episiotomy/perineal tear pain management.
Dr.I.A.Sotande, Prof. S.D. Amanor-Boadu, Dr. I.G. Ismaila, Dr. O. Olasore, Oba Ademola Maternity Centre, Nigeria. OAMCJ 2002.
Abstract: To determine the analgesic efficacy of AEKNIL (Paracetamol) injection for immediate post-episiotomy / perineal tear pain relief in parturient women. Methods: One hundred women who gave birth vaginally and had episiotomy or perineal tear were included in the study. Discussion: Group A received intramuscular acetaminophen (AEKNIL) in addition to xylocaine infiltration of the episiotomy / perineal tear wound before the repair of the wound. Group B received intramuscular injection of Aqua in addition to xylocaine infiltration of the episiotomy / perineal wound before the repair of the wound. After the repair patients were transferred to ward for monitoring of the vital signs and pain assessment. The pain assessment was done every 15 minutes for 4 hours by the research assistant using 10cm visual analog scale. The times of first analgesic requirement were noted and patients were monitored for any complications. Conclusion: The results obtained demonstrate that AEKNIL (Paracetamol) injection has a clear analgesic effect post-episiotomy/perineal tear repair demonstrated by longer time to first analgesic requirement.

3. Use of N-acetylparaaminophenol (Paracetamol) in parenteral form in pediatrics.
Dr.Versha Modi, Dr. A.B.Desai, Department of Pediatrics, B.J.Medical College and Civil Hospital, Ahmedabad, Gujarat, India, Pediatric Clinics of India, July 1974.
Abstract: In this clinical trial, N-Acetyl Para Aminophenol (Paracetamol AEKNIL) was used in the Injectable form mainly to note its antipyretic effects in small children. Methods: Any child in the pediatric ward with temperature above 101°F was taken for study. The children of all age groups including newborn babies were considered for the trial. The cases were alternately given Injection of Analgin or if pyrexia recurred they were given the two antipyretics alternately. 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. The time required to reduce pyrexia was noted. If the pyrexia recurred, the interval was noted and any untoward effects were observed and recorded. 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 mg 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: 0.25 ml/dose up to 1 year of age; 0.5 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. Injection N-Acetyl Para Aminophenol (Paracetamol) was used on 75 occasions in recommended dose. Injection Analgin was used on 50 occasions. Twelve observations when oral antipyretic was administered are also included. The results were graded as Good, Fair, and Poor. Results: The response was good, i.e., the temperature could be lowered to normal within half to 1 hour and the results were identical in both injectable forms. In 89.3% of cases, the response in lowering the temperature was satisfactory. The temperature was brought to normal within 2 hours. Oral administration has been useful in only 50% of the cases. No toxic reactions were encountered in any of these patients either in injectable or oral therapy. Considering the good and the fair response almost in 90% of the cases, the temperature could be brought down to normal within 2 hours. Here also the Injectable forms were equally effective. In the last group where the response was poor, all the cases were of specific diseases like Tetanus, Tuberculosis and Enteric Fever where the temperature could be brought down by 2°F or 3°F but did not touch normal. Conclusion: N-Acetyl Para Aminophenol (Paracetamol) is a very safe drug when given intramuscularly. It can be given safely to all age groups including newborn babies. In all types of illnesses, specific or nonspecific, it is very useful in lowering the temperature to normal within a short time. Even when the temperature did not touch normal, it was lowered by 2°F to 3°F, which brings about considerable relief and comfort to the patients. It is not toxic can be safely used. No local pain was complained of by older children.

4. Therapy of fever with special reference to Paracetamol: A clinical trial.
Dr.Manoranjan Sahai, Department of Pediatrics, Darbhanga Medical College, Laheria Sarai, Bihar, India. DMCJ 1972
Abstract: The aim of this clinical trial is to study the effect of Paracetamol (AEKNIL) on pyrexia. The dose for the antipyretic and analgesic effect of AEKNIL used was 3mg/kg of body weight. The route of administration of the drug was oral and by Injection. Methodology: 60 patients were enlisted in the trial. The effect of the drug in various ranges of pyrexia were observed and the results tabulated as Good (temperature is reduced by 3 to 4°F within 8 to 12 hours of administration of drug.), Fair (temperature was reduced at least by 2°F within 4 to 8 hours of the administration of drug.) and Poor (No reduction in pyrexia after 48 hours treatment.) Discussion: Temperature reduced by 3 to 4°F within 8 to 12 hours of administration of drug in 30 cases. Temperature reduced at least by 2°F within 4 to 8 hours of the administration of drug in others. Conclusion: From the observations done in the Department of Pediatrics, Darbhanga Medical College, Laheria Sarai, Bihar, with AEKNIL Drops and Injection (Paracetamol) under the guidance of Prof. B.N Das Gupta,Professor and Head of the Department of Pediatrics, we conclude that AEKNIL is of considerable value when used as an antipyretic, analgesic drug.

5. Clinical trial with AEKNIL brand of Paracetamol.
Dr.Lohe, Dr. Deshpande, G.T. Hospital, Bombay, India, The Bombay Hospital Journal. Vol. 9, No. 3, July 1967.
Abstract: A clinical trial was carried out in Children's Ward at G.T Hospital, Bombay to study the role of "AEKNIL" as an antipyretic. For control studies, other antipyretics viz., A.P.C Powder and 'Mist Diaphoretic" were used. Three hundred and sixty cases were studied over a period of one year. The cases were divided into three groups as follows: Group 1 included 120 cases treated with "AEKNIL" Group 2 included 120 cases treated with "A.P.C" Group 3 included 120 cases treated with "Mist Diaphoretic". The main aim of the trial was to study the effect of "AEKNIL" in controlling pyrexia irrespective of its etiology. It was used only for symptomatic relief. Specific treatment with antibiotics was given as required. The dosage of the antipyretic used in this trial was 2 mg/kg (Body weight below 10 kg). The antipyretic was administered for 2 to 5 days and the results tabulated. No serious side effects due to AEKNIL were noted in this trial. No cyanosis due to methaemoglobinemia was seen on any occasion. Temperature subsided completely or was reduced by at least 3°F within 12 to 24 hours of administering the drug in 48 cases and fever was reduced by at least 2°F within 24 to 48 hours of administering the drug in 60 cases. Conclusion: AEKNIL is of considerable value when used as an antipyretic in wide range of common pediatric ailments. The great advantage is that it is almost free from any side effect and because of its complete miscibility in water, it could be used both in oral and intra-muscular form.

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