Clinical trial NCT01271608: 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
Overall status: COMPLETED
Phase: NA
Conditions: Knowledge, Attitudes, Practice
Injection Site Reactions
Keywords: Accident prevention
Blood-borne pathogens
Protective devices.
Needlestick injuries
Injections subcutaneous
Injections intradermal
Lead sponsor: Hospital M'Boi Mirim
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 1240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: M Boi Mirim Hospital
Study officials:
affiliation: Conselho Regional de Enfermagem de São Paulo
name: Luiz Carlos R Lamblet, Nurse
role: PRINCIPAL_INVESTIGATOR
References:
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.