Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department
Condition: Pain
MeSH terms: Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to explore to what degree, if any, Jet lidocaine will reduce or
      alleviate pain, as compared to Jet normal saline, in children undergoing needle insertion in
      the Pediatric Emergency Department (PED). If effective, Jet lidocaine would afford a novel
      rapidly acting local anesthesic for children in the PED.
    

Detailed description: 
      This randomized clinical trial involves double blind allocation of either (1) Jet
      administration of buffered 1% lidocaine or (2) Jet normal saline (placebo) prior to needle
      insertion in the PED. The product will be prepackaged on a weekly basis at an off site
      pharmacy into the jet injector system and all devices will be labeled as "study drug" with an
      assigned number. We estimate 30 patients being enrolled in each one-month period and the
      pharmacy will allocate 10 devices of study medication and 10 devices of normal saline. Our
      estimated sample size is 84 patients per group. The study duration will continue until the
      sample size is achieved. An interim analysis of data will be performed after 25% or 21
      patients are obtained in each group.

      A total of 168 patients will be expected to participate in order to achieve our sample size.
      The a priori sample size analysis uses a two tailed student's t-test with an alpha of 0.05
      and a power of The study is open to children of any race or ethnicity. There will be no race
      or ethnicity-based enrollment restrictions or selection factors for the population to be
      included in this study.

      All children presenting to the Pediatric Emergency Department at Bellevue Hospital are first
      triaged by the nursing staff. Triage includes documenting vital signs, a chief complaint, and
      a brief clinical assessment. The physician (resident, fellow, or attending) evaluates the
      patient and repeats a more extensive clinical assessment. Children with clinical evaluations
      and treatment plans that identify a need for needle insertion will be prepared for the
      procedure by a physician, nurse, and/or a Certified Child Life Specialist (CCLS). Preparation
      involves education and support to the parent and/or child before and during the procedure.
      The pre-procedure preparation is a part of the routine care for all children who present to
      the PED and require a procedural intervention.

      Patients will be randomly assigned to receive one of two treatments prior to the procedure.
      The treatment group will receive 0.2 cc of 1% buffered lidocaine via Jet injection, while the
      control group will receive 0.2 cc of normal saline via Jet injection. All patients who
      fulfill enrollment criteria and with whom consent and assent (if appropriate) are obtained
      will be assigned consecutively.

        1. The provider's decision to insert a needle is determined as part of the patient's
           standard care for the diagnosis or treatment of illness. A standard history and physical
           examination will be performed by the ED physician/nurse and includes information
           sufficient to determine patient eligibility. All children undergoing needle insertion
           will be assessed for eligibility by a trained provider based on information routinely
           documented (see above Inclusion/Exclusion Criteria). Children eligible to receive EMLA
           cream will be excluded and will receive EMLA cream routinely. Other anesthetics or
           analgesics will not be withheld from any patient enrolled in this study. The standard
           pre-procedure preparation time will provide an appropriate time period to educate the
           patient and parent about the study and obtain consent. This process will not delay the
           patient's care. Standard non-pharmacologic emotional support and explanations will be
           provided to the patient and/or parent.

        2. For patients meeting inclusion criteria, informed consent will be obtained from the
           parent or legal guardian. Patients who are 18 years of age will provide their own
           consent. Informed assent will also be obtained in children less than 18 years of age.
           Consent and assent will be obtained during the standard pre-procedural preparation time.

        3. If informed consent/assent is obtained, the patient and parent will receive additional
           education about the Jet device. This patient will undergo standard needle insertion by a
           trained provider and concomitantly receive supportive care including, but not limited
           to, age appropriate education, distraction, relaxation, and support.

        4. A Color Analogue pain score (CAS) (see outcome measures section for CAS background and
           description, and fig 2) will be obtained from the patient at the baseline, prior to the
           start of the procedure. The Jet application will occur at the insertion site, prior to
           the needle being inserted into the skin. A CAS pain score will be obtained from the
           patient subsequent to administration of the device. The provider will wait thirty
           seconds prior to insertion of the needle into the skin. A CAS pain score for needle
           insertion will be collected after completion of the procedure. After one minute a post
           procedure CAS score will be collected. The parent and/or support staff will be with the
           child throughout the entire procedure.

        5. After the procedure the provider will document patient demographics, diagnosis, and
           Likert scales for cooperation and ease of insertion (see provider document). The
           provider will ask the parent and child one question related to satisfaction after the
           completion of the procedure.

        6. Patients will be withdrawn from the study if either the patient or caregiver requests
           withdrawal at any time.

        7. After insertion of the needle appropriate diagnostic and therapeutic interventions will
           be continued leading to either hospital admission with the IV or discharge home with
           removal of the IV upon discharge.

      The J-Tip Jet device (National Medical Products, CA) will be purchased as an empty device and
      sent to Dr. Nayan Patel at Central Drugs Pharmacy, CA, for preparation. Central Drugs
      Pharmacy will fill these devices and ship them to Bellevue hospital. The devices will be
      filled and packaged, using aseptic techniques, with either 0.25 cc of normal saline or 0.25
      cc of 1% buffered lidocaine. This device is FDA approved for administration of lidocaine in
      children and is currently used in a number of other institutions at the time of this study.

      Pain, the primary outcome, will be assessed using the Color Analogue pain Scale (CAS) (1-5)
      (see appendix for CAS scale picture). This scale is anchored by descriptors "no pain" and
      "most pain" with gradation in color, area, and length (see attached CAS figure). The point on
      the tool that is identified by the child with the plastic marker on the colored scale front
      side is converted to a corresponding numerical scale from the back of the tool. This number
      is the CAS score in centimeters. This scale has been well validated for use in children over
      five years of age undergoing procedures in the PED with minimal or no training with this
      tool. The following instructions are given prior to use of the scale: "This is a pain scale.
      The bottom, where it is small and white, means no pain, and the top, where it is wider and
      red, means the most pain you can imagine (instructor points to anchor). You slide the marker
      to the spot on the scale that shows how much pain you are having right now. (2)"

      The CAS pain scale will be self-reported by the patient at the site of needle insertion at a
      number of points in time. A 2.5 cm change in CAS is considered clinically significant (11).

        1. Pre-Jet

        2. Jet administration

        3. Insertion of needle into the skin (60 seconds after Jet)

        4. Post-needle insertion (1 minutes after completion of insertion)

      Secondary outcomes will be measured to assess satisfaction. All patients and parents will be
      asked "Based on your IV start today, would you like this numbing medicine in the future?" (8)
      The provider will report satisfaction related to cooperation and "difficulty of finding a
      vein" using a 5-point likert scales. The patient's demographic data, location of placement,
      diagnosis, and number of attempts will be included in the study documentation.

      All data collection sheets will be filed in a locked collection cabinet, to be reviewed only
      by the principal investigators after completion. Study number and age will be identified on
      the data collection document.

      Each child's data collection sheets (See Data Collection Forms) will include their gender,
      ethnicity, date of visit, age, pain scores, and survey data.
    

Intervention name(s): Lidocaine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Jet lidocaine compared to jet placebo before needle insertion; Jet saline
Other intervention name(s): National medical jet injector system
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatric; Pain; Needle; Emergency; Phlebotomy; Intravenous; Lidocaine; Local; Anesthesia