SUMMARY
NOVOCAIN®
PROCAINE HYDROCHLORIDE INJECTION, USP
NOVOCAIN, procaine hydrochloride, is benzoic acid, 4-amino-, 2-(diethylamino) ethyl ester, monohydrochloride, the ester of diethylaminoethanol and aminobenzoic acid.
NOVOCAIN is indicated for spinal anesthesia.
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NEWS HIGHLIGHTS
Clinical Trials Related to Novocaine Intraspinal (Procaine Intraspinal)
Efficacy of the Combination Bismuth + Neomycin + Procaine in the Treatment of Recurrent Aphthous Ulceration [Completed]
To evaluate the efficacy of the product Bismu-Jet ® (bismuth tartrate and sodium, neomycin
sulfate and procaine hydrochloride) produced by EMS S / A compared to placebo in reducing
the signs and symptoms resulting from UAR in patients of both sexes, with age over 12 years.
Simplified Antibiotic Therapy for Sepsis in Young Infants [Completed]
This trial evaluates primary care clinic-based simplified antibiotic therapy options for
young infants, 0-59 days old in high neonatal mortality settings in peri-urban Karachi where
hospital referral is frequently refused by families.
Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants [Active, not recruiting]
Approximately one-third of neonatal deaths in developing countries are due to infections
acquired through the birth canal and/or exposure to an unclean environment soon after birth.
Current World Health Organization recommendations for the management of infants younger than
2 months of age who have serious bacterial infections involve hospitalization and parenteral
therapy for at least 10 days with antibiotic regimens containing penicillin or ampicillin
combined with an aminoglycoside. However, in many settings throughout the developing world,
this is not currently possible, nor is this standard of care likely to be feasible in the
near future. Several studies have reported that for a variety of sociocultural reasons many
families are unable or unwilling to access hospital-based care and their sick young infants
do not get hospitalized, and instead, receive a variety of home-based antibiotic therapies,
or none at all. In our community field sites, approximately 70% of families refuse hospital
referral for a sick newborn, despite provision of transport.
Thus, there is an urgent need to define the role of community/first-level facility-based
care versus hospitalization for the management of young infants with serious bacterial
infections, and the potential for community-based parenteral antibiotics as an alternative
strategy in resource poor areas with high neonatal mortality rates. Bang and colleagues have
demonstrated significant reductions in neonatal mortality from infections in an
underdeveloped rural district in Maharashtra, India by a field-based case management
approach which used oral cotrimoxazole and intramuscular gentamicin given for 7 days as
treatment for neonates with sepsis.
This study is an equivalence randomized controlled trial (RCT) comparing once daily IM
ceftriaxone injection to once daily IM procaine penicillin and gentamicin injection, to once
daily intramuscular gentamicin injection and twice daily oral cotrimoxazole, given for 7
days in babies with clinically-diagnosed possible serious bacterial infection (pneumonia, or
sepsis with or without local infections such as skin or umbilical infections) whose families
refused referral to a hospital. After supplementary informed consent, patients meeting
specific inclusion and exclusion criteria are randomly allocated to one of the three
regimens being tested. The study hypothesis is that all 3 regimens will perform equally well
in the treatment of sepsis in a first-level facility setting.
A Dose Response and Safety Study of Procaine HCl in HIV-Infected Patients [Completed]
This a Phase I/II non-randomized, open-label clinical study of 8 weeks duration using SP01A
in HIV positive patients on a stable antiretroviral regimen. Dose response and safety
associated with oral administration of four doses (200 mg, 400 mg, 600 mg, and 800 mg daily)
of SP01A will be studied in a total of 24 study subjects. In addition, six HIV-negative
subjects will be recruited as a control for cortisol secretion only and will not receive
study medication.
Simplified Antibiotic Regimens for Outpatient Treatment of Suspected Sepsis in Neonates and Young Infants in Bangladesh [Completed]
The primary aim is to establish the non-inferiority of several simplified, home-based
antibiotic regimens compared to the standard course of parenteral antibiotics for the
empiric treatment of suspected sepsis in Bangladeshi young infants whose parents refuse
hospitalization. Three alternative regimens will be compared with a standard (reference)
regimen of injectable procaine-benzyl penicillin and gentamicin once daily each for seven
days. Alternative regimens are (1) injectable gentamicin once daily and oral amoxicillin
twice daily for seven days; (2) injectable penicillin and gentamicin once daily for two days
followed by oral amoxicillin twice daily for five days; and (3) injectable gentamicin once
daily and oral amoxicillin twice daily for two days followed by oral amoxicillin twice daily
for five days.
Hypothesis
The proportion who fails treatment will be 10 percent in the reference group and the
alternative treatment groups. An alternative therapy will be considered non-inferior to the
standard therapy if the failure rate in the alternative therapy exceeds the failure rate in
the injectable therapy by less than 5 absolute percentage points.
Secondary Objectives:
- To identify baseline clinical predictors of treatment failure in severe infections in
young infants.
- To determine the proportion of relapse (young infants who were considered cured by day
7 but developed any of the signs of suspected severe infection by day 14).
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Page last updated: 2007-08-28
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