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Pain Relief During Intravenous Cannulation in Pediatric Patients

NCT04246255 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-08-25

No results posted yet for this study

Summary

Performing intravenous (IV) cannulation to pediatric patients might be much harder than adult ones according to their anxiety levels. However, managing adult patients during intravenous cannulation is also challenging if he or she had a noxious memory about the situation or has a low pain threshold. Therefore, it is essential to relieve the pain of an IV needle or an IV cannula insertion in the pediatric patient population. Lidocaine Hcl spray (Xylocaine 10% Oral ) will be utilized to the research group, and Serum Physiologic (Serum Fizyolojik %0,9 10 ml ampule, Biofarma İlaç San. ve Tic A.Ş., İstanbul, Turkey) will be utilized to the control group of the study. Both medications will be administrated by spraying the formula three times to an adhesive bandage and placing it to the skin that IV cannulation will be performed. After waiting for a minimum of 5 to a maximum of 15 minutes ( waiting time is closely associated with the patient's anxiety level), IV cannulation will be performed from the same area by an experienced pediatric nurse. The investigator hypothesizes that utilizing the spray form of the Lidocaine Hcl formula to the skin with an adhesive bandage before IV cannulation might lower the pain of the manipulation in pediatric patients, which might cause lower anxiety levels with stable vital signs.

Conditions

  • Cannula Site Pain
  • Local Anesthesia

Interventions

DRUG

Xylocaine 10% Oral

50 ml of lidocaine solution maintained from xylocaine 10% oral that transferred to a bottle with a spray pump which pumps 0,1ml for each pump will be used for the experiment. 3 pumps of lidocaine will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted.

DRUG

Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul

50 ml of Serum physiologic in a bottle with a spray pump which pumps 0,1ml for each pump will be used for placebo. 3 pumps of placebo will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted.

Sponsors & Collaborators

  • Yeditepe University

    lead OTHER

Principal Investigators

  • Ferda F Kartufan, Asst.Prof. · Yeditepe University Anesthesiology and Reanimation Department

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
72 Months
Max Age
215 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2020-08-01
Completion
2020-08-24

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04246255 on ClinicalTrials.gov