Jet Lidocaine for Pain Relief During Needle Insertion in a Pediatric Emergency Department.

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.