8 research outputs found
Clinical research in India: Great expectations?
India is considered as a preferred site for conducting global clinical
trials. Existence of a large treatment-naοve population,
availability of English-speaking, skilled doctors, plenty of clinical
material, and cost-savings are obvious advantages for carrying out
clinical research in India. However, challenges exist at various
levels. Lack of formal training in bioethics and research methodology,
heavy burden of clinical duties and sub-optimal administrative support
restrict investigators. Absence of oversight of functioning of ethics
committees (ECs) and lack of mechanisms for ensuring quality of ethics
review heighten societal concerns about safety of participants.
Conducting research on issues not relevant to local needs and failure
to ensure post-trial access further enhance society′s cynicism.
These issues need to be tackled through capacity building, training of
investigators and EC members, strengthening of EC functioning and
encouraging greater community participation
Pharmacokinetics of rectal compared to intramuscular paracetamol in children undergoing minor surgery
Objectives : Although paracetamol is a widely accepted and safe
analgesic, guidelines regarding its definite analgesic dose are
lacking. This study was, therefore, undertaken to compare the
pharmacokinetics of paracetamol when administered by two routes, viz,
intramuscular and rectal, in children undergoing minor surgery.
Design : Randomized, controlled, assessor-blind, comparative clinical
trial. Materials and Methods: Following Institutional Ethics Committee
approval and valid consent, children undergoing minor surgery were
randomized to receive paracetamol either intramuscularly or rectally.
Blood samples were collected at fixed intervals for estimation of drug
levels. Results : Fifty children (43 boys, 7 girls; ages 3 to 12
years; weight 10 to 40 kg) were enrolled in the study. 26 patients were
randomized to receive paracetamol intramuscularly (mean dose 14.8
± 0.9 mg/kg) and 24 to receive the paracetamol as a rectal
suppository (mean dose 29.5 ± 1.4 mg/kg). Complete pharmacokinetic
analysis was possible in only 29 patients, as the blood samples of the
others were either not received or were inadequate for analysis. The
mean maximum plasma concentration (C max ) with rectal paracetamol (n =
13) was 6.04 ± 2.21 mg/ml with a T max of 2.5 ± 0.89 h, while
with intramuscular paracetamol (n = 16), the C max was 10.34 ±
7.09 mg/ml and the T max 1.47 ± 0.64 h. The area under the
concentration-time curve (AUC 0-12 ) was 42.26 ± 22.29
µg.h/ml and 43.60 ± 26.45 µg.hr/ml for rectal and
intramuscular paracetamol, respectively. Patients in the intramuscular
group needed rescue medication earlier as compared to those in the
rectal group (P < 0.05). Conclusion : Although the drug levels
achieved with rectal paracetamol were less than that achieved with
intramuscular administration, it was higher than the lower limit for
analgesic effect (3-5 µg/ml). Patients who received paracetamol
intramuscularly needed rescue medication earlier compared to those
receiving paracetamol rectally, indicating a more prolonged duration of
action with rectally administered paracetamol. Hence, rectal
paracetamol can be used as a safe, effective, and more acceptable
analgesic alternative in children
A critical analysis of the COMPASS trial with respect to benefit-risk assessment using the numbers needed to treat: Applicability and relevance in Indian patients with stable cardiovascular disease
The recently published Cardiovascular Outcomes for People Using Anticoagulation Strategies (COMPASS) trial evaluated the hypothesis that rivaroxaban alone or in combination with aspirin would be more effective than aspirin alone for secondary prevention. In India, stable cardiovascular disease occurs in a much younger age group relative to the rest of the world.Our critical analysis of COMPASS trial showed that the younger age group appeared to derive greater benefit from the rivaroxaban + aspirin combination (relative to aspirin alone) as seen with number needed to treat metrics as compared to the older age group. Keywords: Stable Coronary artery disease, Rivaroxaban, Young Indian Population, Likelihood of being helped and harme