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Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency Department

A Comparison of 18-Gauge and 20-Gauge Intravenous Cannulas in Terms of Pain and Procedural Difficulty: A Randomized Controlled Trial in the Emergency Department

Peripheral intravenous catheter (PIVC) insertion is one of the most frequently performed invasive procedures in both medical and nursing practice. It is essential for blood sampling, intravenous (IV) fluid resuscitation, medication administration, blood product transfusion, and IV contrast-enhanced radiological imaging. In emergency department (ED) settings, where patients may deteriorate rapidly, timely and adequate IV access is of critical importance. Larger-bore cannulas allow faster fluid and contrast delivery and are less prone to occlusion; however, Larger-bore cannulas are often perceived to cause greater pain and procedural difficulty compared to smaller-bore cannulas. This perception may lead clinicians to prefer smaller cannulas, potentially compromising care quality in patients who may unexpectedly deteriorate.

Cannula insertion inherently causes discomfort, pain, and anxiety for patients, and multiple failed attempts further amplify these effects. Patient satisfaction, an important dimension of overall care quality, is directly influenced by pain experience and the number of insertion attempts. Patients requiring two or more attempts for successful cannulation are generally classified as having difficult intravenous access (DIVA). Repeated failed attempts are associated with vascular injury, increased patient distress, delays in diagnosis and treatment, and greater consumption of healthcare resources. The A-DIVA score, developed by Van Loon et al., enables risk stratification for IV access difficulty at triage, classifying patients as low, moderate, or high risk, and facilitating proactive measures such as ultrasound guidance or involvement of experienced personnel for high-risk patients.

This single-center, prospective, single-blind, randomized controlled trial aims to compare 18-gauge (18G) and 20-gauge (20G) PIVCs in terms of patient-reported pain intensity and nurse-reported procedural difficulty in adult ED patients with low-to-moderate A-DIVA risk. The investigators hypothesize that 18G cannulas cause similar pain and procedural difficulty compared to 20G cannulas in this patient population.

The study will be conducted at Marmara University Pendik Training and Research Hospital Emergency Department. Ethics approval has been granted by the Marmara University Faculty of Medicine Clinical Research Ethics Committee. Adult patients (18 years and older) requiring IV access for diagnostic or therapeutic purposes and classified as low or moderate A-DIVA risk will be eligible. Patients with cognitive impairment, altered mental status, or hemodynamic instability (systolic BP less than 90 mmHg or mean arterial pressure less than 65 mmHg) will be excluded.

Eligible consenting patients will be randomized 1:1 using a block randomization method (block size of 4) to either 18G or 20G cannula insertion. Cannula assignment will be delivered to nurses in sealed envelopes. Patients will be blinded to cannula size using blackout goggles. Cannulation will be performed by ED nurses following standard antiseptic and securement procedures, targeting the dorsum of the hand, forearm, or antecubital fossa. If the first attempt fails, at least one additional attempt with the assigned cannula will be required before allowing free choice of cannula and site.

The primary outcomes are patient-reported pain intensity and nurse-reported procedural difficulty, each assessed using a 10 cm Visual Analog Scale (VAS) immediately after the first cannulation attempt and compared between the 18G and 20G cannula groups. Secondary outcomes include the comparison of first-attempt cannulation success rate between the 18G and 20G cannula groups. This comparison will also be performed separately according to cannulation site, operator experience, A-DIVA risk category, patient age, and patient sex.

A total of 204 patients (102 per group) will be enrolled, based on 90% power, 5% type I error, a minimum clinically important difference of 13 mm on the VAS, and a 10% dropout allowance.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

204

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Istanbul, Tyrkia (Türkiye)
        • Marmara University Pendik Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

  • 18 years of age or older
  • Requiring intravenous access for diagnostic or therapeutic purposes
  • Classified as low or moderate risk according to the A-DIVA (Adult Difficult Intravenous Access) score
  • Provision of informed consent by the patient, a relative, or a legal guardian

Exclusion Criteria:

  • Inability to effectively communicate pain intensity due to cognitive impairment, altered mental status, or visual or language difficulties
  • Hemodynamic instability defined as systolic blood pressure less than 90 mmHg or mean arterial pressure less than 65 mmHg

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 18G Cannula Group
Participants in this arm will undergo peripheral intravenous cannulation using an 18-gauge (18G, green) cannula. Cannulation will be performed by emergency department nurses targeting the dorsum of the hand, forearm, or antecubital fossa following standard antiseptic and securement procedures. If the first attempt fails, at least one additional attempt with the assigned 18G cannula will be made before allowing free choice of cannula and site.
Peripheral intravenous cannulation performed using an 18-gauge (18G, green) cannula inserted into the dorsum of the hand, forearm, or antecubital fossa by an emergency department nurse following standard antiseptic and securement procedures. No local anesthetic agents will be used. Patients will be blinded to cannula size using blackout goggles.
Aktiv komparator: 20G Cannula Group
Participants in this arm will undergo peripheral intravenous cannulation using a 20-gauge (20G, pink) cannula. Cannulation will be performed by emergency department nurses targeting the dorsum of the hand, forearm, or antecubital fossa following standard antiseptic and securement procedures. If the first attempt fails, at least one additional attempt with the assigned 20G cannula will be made before allowing free choice of cannula and site.
Peripheral intravenous cannulation performed using a 20-gauge (20G, pink) cannula inserted into the dorsum of the hand, forearm, or antecubital fossa by an emergency department nurse following standard antiseptic and securement procedures. No local anesthetic agents will be used. Patients will be blinded to cannula size using blackout goggles.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pain intensity
Tidsramme: Immediately after the first cannulation attempt
Patient-reported pain intensity assessed using a 10 cm Visual Analog Scale (VAS) after the first cannulation attempt, compared between the 18G and 20G cannula groups. The VAS score ranges from 0 (no pain) to 10 (worst imaginable pain). The unit of measure is the score on the Visual Analog Scale (0-10 cm).
Immediately after the first cannulation attempt
Procedural difficulty
Tidsramme: Immediately after the first cannulation attempt
Nurse-reported procedural difficulty assessed using a 10 cm Visual Analog Scale (VAS) after the first cannulation attempt, compared between the 18G and 20G cannula groups. The VAS score ranges from 0 (no difficulty) to 10 (worst imaginable difficulty). The unit of measure is the score on the Visual Analog Scale (0-10 cm)
Immediately after the first cannulation attempt

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
First-attempt cannulation success rate
Tidsramme: Immediately after the first cannulation attempt
The proportion of participants with successful cannulation achieved on the first attempt, compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by cannulation site between groups
Tidsramme: Immediately after the first cannulation attempt
The first-attempt cannulation success rate at each cannulation site (dorsum of hand, forearm, or antecubital fossa), assessed by procedural documentation, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per site (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by operator experience between groups
Tidsramme: Immediately after the first cannulation attempt
The first-attempt cannulation success rate across different levels of operator experience, assessed in years of clinical experience, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per operator experience level (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by A-DIVA score between groups
Tidsramme: Immediately after the first cannulation attempt
The first-attempt cannulation success rate across A-DIVA risk categories, assessed using the Adult Difficult Intravenous Access (A-DIVA) scoring tool, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per A-DIVA risk category (%). The A-DIVA score ranges from 0 to 5, with scores of 0-1 indicating low risk, 2-3 indicating moderate risk, and 4-5 indicating high risk of difficult intravenous access.
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by patient age between groups
Tidsramme: Immediately after the first cannulation attempt
The first-attempt cannulation success rate across different age groups, recorded in years at the time of enrollment, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per age group (%).
Immediately after the first cannulation attempt
Comparison of first-attempt cannulation success rate by patient sex between groups
Tidsramme: Immediately after the first cannulation attempt
The first-attempt cannulation success rate by patient sex (male or female), recorded at the time of enrollment, will be compared between the 18G and 20G cannula groups. The unit of measure is the percentage of participants with successful first-attempt cannulation per sex (%).
Immediately after the first cannulation attempt

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Erhan Altunbas, Marmara University Scholl Of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

23. juli 2026

Primær fullføring (Faktiske)

30. juli 2026

Studiet fullført (Faktiske)

3. august 2026

Datoer for studieregistrering

Først innsendt

13. mai 2026

Først innsendt som oppfylte QC-kriteriene

4. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. august 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 09.2026.774

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

Nei

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