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Updated: Jun 10, 2026

Determining heat and mechanical pain threshold in inflamed skin of human subjects
Published on: January 14, 2009
Contribution of a heating element to topical anesthesia patch efficacy prior to vascular access: results from two
Salman Masud1, Richard D Wasnich, Jon L Ruckle
1Shriners Hospitals for Children, University of Utah, Salt Lake City, Utah 84103-4399, USA. smasud@shrinenet.org
Insights
A heated topical anesthetic patch significantly reduced pain during IV procedures compared to an unheated version. This innovation offers improved pain management for superficial procedures, especially in pediatric patients.
Area of Science:
- Anesthesiology
- Dermatology
- Pain Management
Background:
- Pain during superficial procedures like IV access is a significant concern, particularly for pediatric patients.
- Effective pain prevention strategies are crucial for improving patient experience and procedural success.
Purpose of the Study:
- To evaluate a novel topical anesthetic patch combining lidocaine and tetracaine with a heating element.
- To assess the impact of controlled heat on the efficacy of the lidocaine/tetracaine patch for pain reduction during IV cannulation.
Main Methods:
- A pilot study randomized subjects to heated vs. unheated patches, varying application times and catheter sizes.
- A definitive double-blind study randomized subjects to heated or unheated patches (20-minute application) before IV cannulation.
- Pain intensity was measured using a visual analog scale (VAS) as the primary efficacy endpoint.
Main Results:
- The heated patch group reported significantly lower mean pain intensity scores (14.7 mm) compared to the unheated group (23.5 mm) in the pilot study (P=0.04).
- In the definitive study, mean pain scores were significantly lower for the heated patch group (14.2 mm) versus the unheated group (20.5 mm) (P=0.006).
- Catheter size showed a trend towards significance in pain reduction in the pilot study.
Conclusions:
- Heated lidocaine/tetracaine patches provide superior pain relief compared to unheated patches for IV procedures.
- The heated patch was well-tolerated with minimal adverse effects.
- Controlled heat enhances the efficacy of topical local anesthetics for superficial pain management.
Context:
Pain associated with superficial procedures, including intravenous (IV) access procedures, should be prevented when possible, especially in children.
Objectives:
To evaluate a topical local anesthetic patch containing lidocaine 70 mg/tetracaine 70 mg with a heating element designed to warm the skin and facilitate rapid delivery of local anesthetics into the skin. The pilot study was designed to provide data to inform the design of the definitive study to evaluate the impact of controlled heat on the efficacy of the lidocaine/tetracaine patch (patch) when applied before IV cannulation.
Methods:
Subjects in the pilot study were randomized to eight groups that varied by heated vs. unheated patch, 20 vs. 30 minute application, and 16 vs. 18 G catheter. Subjects in the definitive study were randomized in a double-blind manner to receive either the heated or unheated patch, 20 minutes before vascular access, using a 16 G catheter in the antecubital space of the arm. In both studies, the primary efficacy measure was subject-reported pain intensity using a visual analog scale.
Results:
Pilot study: Subjects who received the heated patch (n=43) vs. the unheated patch (n=37) had lower mean pain intensity scores (14.7 vs. 23.5mm, P=0.04). Pain intensity scores did not differ significantly by application time, but the difference between the 16 and 18 G catheter groups approached statistical significance (22.8 vs. 14.9 mm, P=0.05). Definitive study: Mean pain intensity scores for the heated patch group (n=124) vs. the unheated patch group (n=126) were 14.2 and 20.5mm, respectively (P=0.006).
Conclusion:
Heated patches provided significantly better pain relief compared with unheated patches. All the subjects tolerated the patches well, with few adverse effects.
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