Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.
Primary Purpose
Knowledge, Attitudes, Practice, Injection Site Reactions
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
needle exchange
Sponsored by
About this trial
This is an interventional supportive care trial for Knowledge, Attitudes, Practice focused on measuring Accident prevention, Blood-borne pathogens, Protective devices., Needlestick injuries, Injections subcutaneous, Injections intradermal
Eligibility 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.
Sites / Locations
- M Boi Mirim Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01271608
Brief Title
Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.
Official Title
Intramuscular and Subcutaneous Injections: is it Necessary to Have Needles Exchanged?
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hospital M'Boi Mirim
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knowledge, Attitudes, Practice, Injection Site Reactions
Keywords
Accident prevention, Blood-borne pathogens, Protective devices., Needlestick injuries, Injections subcutaneous, Injections intradermal
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1240 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
needle exchange
Intervention Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luiz Carlos R Lamblet, Nurse
Organizational Affiliation
Conselho Regional de Enfermagem de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
M Boi Mirim Hospital
City
São Paulo
ZIP/Postal Code
04948-970
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
22030569
Citation
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. doi: 10.1590/s0104-11692011000500002. English, Portuguese, Spanish.
Results Reference
derived
Learn more about this trial
Study to Evaluate the Need of Needle Change for Application of Intramuscular, Subcutaneous and Intradermal Injection.
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