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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.

Aperçu de l'étude

Type d'étude

Interventionnel

Inscription (Réel)

204

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Double

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Comparateur actif: 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.
Comparateur actif: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Pain intensity
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
First-attempt cannulation success rate
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Erhan Altunbas, Marmara University Scholl Of Medicine

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

23 juillet 2026

Achèvement primaire (Réel)

30 juillet 2026

Achèvement de l'étude (Réel)

3 août 2026

Dates d'inscription aux études

Première soumission

13 mai 2026

Première soumission répondant aux critères de contrôle qualité

4 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 août 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

3 août 2026

Dernière vérification

1 juin 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 09.2026.774

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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