Pain Relief During Intravenous Cannulation in Pediatric Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-03

Study Completion Date

2020-08-24

Brief Summary

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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.

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Detailed Description

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The G-Power 3.0.10. Computed required sample size (alpha:0.05, effect size:0.3 and power 0.8) related to t-test of the difference between two dependent means(matched pairs) according to the 5% change of before and after heartbeat outcome parameters with Standard derivations of ( -/+12 to +/-15). The total sample size of ninety participants is evaluated to be enough for the study. However, fifty participants are planned to be enrolled in each group (a total of 100 participants) to compensate for possible losses in this prospective, randomized clinical study. Six parameters will be evaluated, and three scales will be performed in each group. The six parameters are Heart Rate-1, Spo2-1, Body Temperature-1, Heart Rate-2, Spo2-2, Body Temperature-2. The three scales are 11 point Verbal Numeric Rating Scale-1, 11 point Verbal Numeric Rating Scale-2, and Visual Analog Scale. Those parameters will be measured non-invasively, without causing any pain.

The randomization is planned to be done with the sealed envelope modeling. One of the envelopes is planned to be chosen by each participant after the written consent form approval from the child and his/her parents. The envelopes have either a "C" letter or "L" letter inside representing C as {Group C: "The Control Group"}, representing L as {Group L: "The Lidocaine Group"} will be opened by the principal investigator. The bottle 1(Serum Physiologic inside) or bottle 2( Lidocaine inside) will be given to the ward nurse according to the letters in the envelope. The ward nurse will be blinded according to the ingredients in the bottles. The outcome parameters and the scales will be recorded by the nurse in the investigation. The nurse in the investigation will be blinded about the groups, the envelopes and the ingredients performed to the participants.

The study is planned to last in 4 months (16 weeks) time. However, in the middle of the study( 25 participants undertaken within each group), post-doc tests are planned to be done. If the power of the study according to the post-Hoc tests are more than 80%, the study will be stopped.

Conditions

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Cannula Site Pain Local Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group C

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type 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.

Group L

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

Group Type EXPERIMENTAL

Xylocaine 10% Oral

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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EJACERA%10 sprey LINCAINE sprey %10 LOCANEST sprey %10 PRECOXIN %10 sprey VEMCAINE pump sprey %10 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

Eligibility Criteria

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Inclusion Criteria

* 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.