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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:
Information provided by:
Hospital M'Boi Mirim
ClinicalTrials.gov Identifier:
NCT01271608
First received: January 6, 2011
Last updated: NA
Last verified: June 2009
History: No changes posted

January 6, 2011
January 6, 2011
June 2009
June 2009   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Knowledge, Attitudes, Practice
  • Injection Site Reactions
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.
Not Provided
Lamblet LC, Meira ES, Torres S, Ferreira BC, Martucchi SD. Randomized clinical trial to assess pain and bruising in medicines administered by means of subcutaneous and intramuscular needle injection: is it necessary to have needles changed? Rev Lat Am Enfermagem. 2011 Sep-Oct;19(5):1063-71. English, Portuguese, Spanish.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1240
November 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01271608
CAAE-0203.0.028.000-08
Yes
Luiz Carlos Ribeiro Lamblet/ Nurse, Hospital M Boi Mirim
Hospital M'Boi Mirim
Not Provided
Principal Investigator: Luiz Carlos R Lamblet, Nurse Conselho Regional de Enfermagem de São Paulo
Hospital M'Boi Mirim
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP