Procedural Pain Acute Pain
Conditions
Interventions
This is a randomized controlled non-inferiority clinical trial with two arms, single-blind, with a total of 170 participants, 85 allocated to the intervention group receiving peripheral venous cannula
Sponsors
Serviço Social da Construção Civil do Estado de São Paulo
Serviço Social da Construção Civil do Estado de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients undergoing elective surgery at Hospital Regional de Cotia; of both sexes; with a minimum age of 18 years
Exclusion criteria
Exclusion criteria: Patients under 18 years of age. Patients with difficulty effectively communicating pain intensity due to cognitive impairment, altered mental status, or visual and/or language limitations. Previous venipunctures performed before arrival at the surgical center. Patients without suitable veins on the dorsum of the hand. Patients in whom the specialist judges there to be technical difficulty or impossibility for cannulation in the allocated group. Healthcare professionals who may distinguish catheter gauge by the color and/or size of the catheter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to evaluate pain intensity immediately after peripheral venous cannulation in participants undergoing cannulation with 18-gauge and 20-gauge catheters, assessed using the Numerical Verbal Scale immediately after the procedure. Sample size calculation was performed considering an expected mean of 2.7 points, a non-inferiority margin of 0.81, statistical power of 90%, and a significance level of 5%, and differences between groups will be evaluated using the Two One-Sided Tests method, Bayesian analysis, intention-to-treat analysis, per-protocol analysis, and Complier Average Causal Effect analysis to determine the effect of the intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to evaluate the success rate of peripheral venous puncture on the first attempt in participants undergoing puncture with 18G and 20G catheters, verified through direct observation of the procedure. The frequencies and percentages of first-attempt success between the groups will be observed.and the data will be analyzed using the chi-square test, Fisher’s exact test, Shapiro-Wilk test, and Mann-Whitney test.;It is expected to evaluate the difficulty of peripheral venous puncture in participants undergoing puncture with 18G and 20G catheters, verified through the application of a Likert-type scale. The frequencies and percentages of punctures classified as easy, moderate, or difficult between the groups will be observed and the data will be analyzed using the chi-square test, Fisher’s exact test, Shapiro-Wilk test, and Mann-Whitney test.;It is expected to evaluate the occurrence of hematoma related to peripheral venous puncture in participants undergoing puncture with 18G and 20G catheters, verified through direct observation of the puncture site. The frequencies and percentages of hematoma occurrence between the groups will be observed and the data will be analyzed using the chi-square test, Fisher’s exact test, Shapiro-Wilk test, and Mann-Whitney test.;It is expected to evaluate the occurrence of infiltration related to peripheral venous puncture in participants undergoing puncture with 18G and 20G catheters, verified through direct observation of the procedure and puncture site. The frequencies and percentages of infiltration occurrence between the groups will be observed e and the data will be analyzed using the chi-square test, Fisher’s exact test, Shapiro-Wilk test, and Mann-Whitney test.;It is expected to evaluate the occurrence of extravasation related to peripheral venous puncture in participants undergoing puncture with 18G and 20G catheters, verified through direct observation of the puncture site. The frequencies and percentages of extravasa | — |
Countries
BR
Contacts
Public ContactPedro Carvalho
Serviço Social da Construção Civil do Estado de São Paulo
Outcome results
None listed