Pain Relief During Intravenous Cannulation in Pediatric Patients

NCT04246255 | Completed Phase 4 DMC

• 1 other identifier: KAEK 882
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Local Anesthesia, Cannula Site Pain, Lidocaine Hydrocloride

Outcome Measures

Primary Outcomes (6)

• Heart Rate-1

  Heart Beat per minute, data obtained from SpO2 pediatric probe, before IV cannula insertion

  It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• SpO2-1

  Peripheral Oxygen concentration, data obtained from SpO2 pediatric probe, before IV cannula insertion.

  It is going to be measured in the first minute(1st min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• Body Temperature-1

  Body temperature, data obtained from tympanic temperature, before IV cannula insertion

  It is going to be measured in the second minute(2nd min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• Heart Rate-2

  Heart Beat per minute, data obtained from SpO2 pediatric probe, after IV cannula insertion

  It is going to be measured in the last 5 minutes period of the study(approximately in the 12th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• SpO2-2

  Peripheral Oxygen concentration, data obtained from SpO2 pediatric probe, after IV cannula insertion.

  It is going to be measured in the last 5 minutes period of the study(approximately in the 12th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• Body Temperature-2

  Body temperature, data obtained from tympanic temperature, after IV cannula insertion

  It is going to be measured in the last 5 minutes period of the study(approximately in the 13th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

Secondary Outcomes (3)

• 11-point Verbal Numeric Rating Scale-1 (VNS-1)

  It is going to be measured in the third minute(3rd min) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• Visual Analog Scales

  It is going to be measured in the in the last 5 minutes period of the study(approximately in the 14th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

• 11-point Verbal Numeric Rating Scale-2 (VNS-2)

  It is going to be measured in the in the last 5 minutes period of the study(approximately in the 15th minute) of the total 15 mins. study, for each participant, through study completion up to 16 weeks.

Study Arms (2)

Group C

PLACEBO COMPARATOR

Serum Physiologic %0,9 ampules ; 0,3ml {spraying three times from a pump spray bottle that sprays 0,1 ml each time to Tegaderm + (2,5 cm x 4 cm) Non-Adherent Pad} 10 minutes before the IV cannula application

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

Group L

EXPERIMENTAL

xylocaine %10 pump spray ; 30mg lidocaine {spraying three times from a pump spray bottle that sprays 0,1 ml each time to Tegaderm + (2,5 cm x 4 cm) Non-Adherent Pad} 10 minutes before the IV cannula application

Drug: Xylocaine 10% Oral

Interventions

Xylocaine 10% Oral DRUG

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.

Also known as: EJACERA%10 sprey, LINCAINE sprey %10, LOCANEST sprey %10, PRECOXIN %10 sprey, VEMCAINE pump sprey %10

Group L

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

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.

Also known as: Serum Fizyolojik Onfarma 10 Ml, 10 Ampul,, Serum Fizyolojik İzotonik %0,9 10 Ml, 100 Ampul, Serum Fizyolojik Biofarma % 0,9, 10 Ml 100 Ampul

Group C

Eligibility Criteria

• Age: 72 Months - 215 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• The subject has to be treated with any drug submitted via intravenous cannula.
• The subject weighted more than 10 kg.
• The subject has a maximum ASA-2 score.

You may not qualify if:

• Allergic to amide group local anesthetics.
• The subject has a dermatological disease.

Sponsors & Collaborators

• Yeditepe University: lead

Study Sites (1)

Yeditepe University

Istanbul, İçerenköy, Turkey (Türkiye)

Location

Related Publications (2)

• Cozzi G, Borrometi F, Benini F, Neri E, Rusalen F, Celentano L, Zanon D, Schreiber S, Ronfani L, Barbi E. First-time success with needle procedures was higher with a warm lidocaine and tetracaine patch than an eutectic mixture of lidocaine and prilocaine cream. Acta Paediatr. 2017 May;106(5):773-778. doi: 10.1111/apa.13764. Epub 2017 Feb 21.

  PMID: 28130888 BACKGROUND

• Kim WO, Song BM, Kil HK. Efficacy and safety of a lidocaine/tetracaine medicated patch or peel for dermatologic procedures: a meta-analysis. Korean J Anesthesiol. 2012 May;62(5):435-40. doi: 10.4097/kjae.2012.62.5.435. Epub 2012 May 24.

  PMID: 22679540 BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Ferda F Kartufan, Asst.Prof.

  Yeditepe University Anesthesiology and Reanimation Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, MD

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: February 3, 2020
• Primary Completion: August 1, 2020
• Study Completion: August 24, 2020
• Last Updated: August 25, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)