Pain Relief During Intravenous Cannulation in Pediatric Patients
Condition: Cannula Site Pain; Local Anesthesia
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      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.
    

Intervention name(s): Xylocaine 10% Oral; Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul
Intervention type(s): Drug; Drug
Intervention description(s): 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.; 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.
Other intervention name(s): 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
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Local Anesthesia, Cannula Site Pain, Lidocaine Hydrocloride