Knowledge, Attitudes, Practice Clinical Trial
Official title:
Intramuscular and Subcutaneous Injections: is it Necessary to Have Needles Exchanged?
Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous
injection between a retractable fixed syringe needle and the technique involving needle
exchange; Comparing bruise formation following administration of insulin subcutaneous
injections between RFS and the conventional technique.
Method Study site A clinical trial was conducted in two medical-surgical units in a hospital
in the period from June 15th to November 30th, 2009, after approval by the Ethics and
Research Committee.
Intervention In a group of patients the investigators used syringes with retractable fixed
needle to administer subcutaneous and intramuscular injections. In the group of control, the
investigators used the standard technique to administer medications.
Population of study Patients were sequentially enrolled through a lottery system of exposure
using random numbers kept in sealed, opaque envelopes.
Sampling design and sample size Subcutaneous injection The sample size was based on the
expected proportion of bruising following the injection. It was expected that 40% of
patients would show bruising with the conventional technique and 20% with the technique
under study for subcutaneous applications. With an alpha error of 5% (p = 0.05) and power of
study of 80% (beta error of 20% or 0.2) 240 patients were included, 120 in each group.
Intramuscular injection The sample size was based on the proportion of patients with
moderate to severe pain. It was considered normal the incidence of moderate to severe pain
in 30% with a needle exchange, whereas it was considered an increase of up to 40% with the
retractable fixed needle. The investigators included 500 patients in each group.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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