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Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01271608
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hospital M'Boi Mirim
  Purpose

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 Intervention
Knowledge, Attitudes, Practice Injection Site Reactions Device: needle exchange

Study Type: Interventional
Study Design: Allocation: Randomized
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?

Further study details as provided by Hospital M'Boi Mirim:

Enrollment: 1240
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: needle exchange
    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 retractable fixed needle and the conventional technique.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The investigators included all patients over 18 who agreed to participate in the study for subcutaneous and intramuscular injections. The monitoring was done after the reading, comprehension check, and signing of the Term of Free Consent and Clarification.

Exclusion Criteria:

  • The investigators excluded patients taking anticoagulants or those who had coagulation disorders, injuries, or skin changes.
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Brazil
M Boi Mirim Hospital
São Paulo, Brazil, 04948-970
Sponsors and Collaborators
Hospital M'Boi Mirim
Investigators
Principal Investigator: Luiz Carlos R Lamblet, Nurse Conselho Regional de Enfermagem de São Paulo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Luiz Carlos Ribeiro Lamblet/ Nurse, Hospital M Boi Mirim
ClinicalTrials.gov Identifier: NCT01271608     History of Changes
Other Study ID Numbers: CAAE-0203.0.028.000-08
First Submitted: January 6, 2011
First Posted: January 7, 2011
Last Update Posted: January 7, 2011
Last Verified: June 2009

Keywords provided by Hospital M'Boi Mirim:
Accident prevention
Blood-borne pathogens
Protective devices.
Needlestick injuries
Injections subcutaneous
Injections intradermal