Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.
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|ClinicalTrials.gov Identifier: NCT01271608|
Recruitment Status : Completed
First Posted : January 7, 2011
Last Update Posted : January 7, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Knowledge, Attitudes, Practice Injection Site Reactions||Device: needle exchange||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1240 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Intramuscular and Subcutaneous Injections: is it Necessary to Have Needles Exchanged?|
|Study Start Date :||June 2009|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||November 2009|
Device: needle exchange
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01271608
|M Boi Mirim Hospital|
|São Paulo, Brazil, 04948-970|
|Principal Investigator:||Luiz Carlos R Lamblet, Nurse||Conselho Regional de Enfermagem de São Paulo|