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A randomized controlled trial to evaluate S-Caine patch for reducing pain associated with vascular access in children
Navil F Sethna1, Susan T Verghese, Raafat S Hannallah
1Harvard Medical School, Department of Anesthesiology, Perioperative and Pain Medicine, Children's Hospital Boston, MA, USA. navil.sethna@childrens.harvard.edu
Insights
The S-Caine Patch effectively reduced pain during venipuncture in children. This lidocaine and tetracaine patch significantly improved pain relief compared to placebo, with most children reporting no pain.
Area of Science:
- Pediatric Anesthesiology
- Pain Management
- Dermatology
Background:
- Venipuncture is a common and often painful procedure for children.
- Effective pain management during pediatric venipuncture is crucial for patient comfort and cooperation.
- The S-Caine Patch, a eutectic mixture of lidocaine and tetracaine, was investigated for its efficacy in reducing venipuncture pain.
Purpose of the Study:
- To evaluate the efficacy and safety of the S-Caine Patch for pain relief during pediatric venipuncture.
- To compare the S-Caine Patch to a placebo patch in a randomized, double-blinded trial.
- To assess the degree of pain reduction using validated pain scales and observer ratings.
Main Methods:
- A randomized, double-blinded trial involving 64 children undergoing venipuncture.
- Participants were assigned to receive either the S-Caine Patch or a placebo patch for 20 minutes prior to the procedure.
- Pain was assessed using the Oucher pain scale, investigator ratings, and independent observer scores.
Main Results:
- The S-Caine Patch group reported significantly lower pain scores (median 0) compared to the placebo group (median 60; P < 0.001).
- 59% of children using the S-Caine Patch reported no pain, versus 20% in the placebo group.
- Investigator and observer ratings also showed significantly greater pain reduction with the S-Caine Patch (P = 0.001 and P < 0.001, respectively).
- Mild skin erythema and edema occurred at similar rates in both groups.
Conclusions:
- A 20-minute application of the S-Caine Patch is effective in reducing venipuncture pain in children.
- The S-Caine Patch is a safe option, with adverse events being mild and transient.
- The study supports the use of the S-Caine Patch for improving pediatric procedural pain management.
Background:
A randomized, double-blinded trial was performed to evaluate the efficacy and safety of the S-Caine Patch (ZARS, Inc., Salt Lake City, UT), a eutectic mixture of lidocaine and tetracaine, for pain relief during venipuncture in children.
Methods:
With institutional review board approval, parental consent, and patient assent, 64 children who were scheduled for medically indicated vascular access at two centers were randomly assigned (2:1) to receive either an S-Caine Patch or a placebo patch for 20 min before venipuncture procedures. The primary outcome measure was the child's rating of pain during venipuncture using the Oucher pain scale. Additional measures of efficacy included the blinded investigator's and an independent observer's four-point categorical scores. Variables were compared between treatments using Mantel-Haenszel summary chi-square tests or Pearson chi-square tests.
Results:
The S-Caine Patch produced significantly greater pain relief compared with placebo (median Oucher scores of 0 vs. 60; P < 0.001). Fifty-nine percent of the children in the S-Caine Patch group reported no pain compared with 20% of the children in the placebo patch group. The investigator estimated that 76% of the children in the S-Caine Patch group experienced no pain during venipuncture versus 20% in the placebo patch group (P = 0.001). Independent observer ratings also favored the S-Caine Patchtrade mark (P < 0.001). Mild skin erythema (< 38%) and edema (< 2%) occurred with similar frequencies between the groups.
Conclusion:
This study demonstrated that a 20-min application of the S-Caine Patch is effective in lessening pain associated with venipuncture procedures. Adverse events after S-Caine Patch application were mild and transient.
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