A Randomized Clinical Trial of Jet-Injected Lidocaine to Reduce Venipuncture Pain for Young Children

Abstract

Study objective: The J-Tip (National Medical Products Inc, Irvine, CA) uses air instead of a needle to push lidocaine into the skin. To our knowledge, no studies have investigated its use for venipuncture in young children. We determine whether the J-Tip decreased venipuncture pain in young children compared with vapocoolant spray.

Methods: Children aged 1 to 6 years were randomized into 3 groups: intervention (J-Tip), control (vapocoolant spray), and sham (vapocoolant spray and pop of an empty J-Tip). The procedure was videotaped and scored with the Face, Legs, Activity, Cry and Consolability (FLACC) tool at 3 points; baseline, before approach; device, at J-Tip deployment; and at venipuncture. The FLACC tool was scored 0 (none) to 10 (severe). Comparisons of pain scores over time were made with the generalized estimating equation. Venipuncture success and adverse effects were assessed and compared with χ(2).

Results: Two hundred five children enrolled: intervention 96, control 53, and sham 56. There were no between-group differences in baseline characteristics. There was no mean change in pain scores from device to venipuncture in the intervention group (0.26; 95% confidence interval [CI] -0.31 to 0.82), but there was an increase in pain in the control (2.82; 95% CI 1.91 to 3.74) and sham (1.68; 95% CI 0.83 to 2.52) groups. This change was greater for the control and sham compared to the intervention group. There was no difference in venipuncture success between groups. No severe adverse events occurred. Minor adverse events were the same between groups.

Conclusion: Use of the J-Tip for children aged 1 to 6 years reduced venipuncture pain compared with vapocoolant spray or sham treatment.

Figure 1. Photo of J tip Device

This image was used with permission from National Medical Products, Inc

Figure 2. Study flow

This depicts the procedure that was videotaped from the time the patient enters the room (left), until the patient was fully consoled (right). The video was then edited to show 3 time frames depicted above: Baseline (T1) – from the time the patient enters the room until right before J tip deployment or researcher report. Device (T2): Immediately after the J tip deployment or Researcher approach until immediately prior to venipuncture, including administration of spray and Venipuncture (T3): At venipuncture until the child was fully consoled. The actual J tip deployment or Researcher approach was removed for blinding.

Figure 3. Enrollment Flow Diagram

Figure 4. FLACC pain scores at each time: (T1) Baseline (T2) Device and (T3) Venipuncture. (solid horizontal line represents median, box represents interquartile range and whiskers represent range)

Figure 5. Changes in FLACC pain scores for individual patients

Parallel lines represent changes in FLACC pain score and changes in FLACC pain score from Device (T2) to Venipuncture (T3) compared between Intervention and (a) Control and (b) Sham and from Baseline (T1) to Venipuncture (T3) compared between Intervention and (c) Control and (d) Sham. The boxplots on the sides represent FLACC pain scores. The solid horizontal lines represent median, the dashed line represents mean, boxes represent interquartile range and whiskers represent range.