Chiragkumar Desai1, Fiona M Wood2, Stephan A Schug3, Richard W Parsons4, Charles Fridlender5, Vivian Bruce Sunderland4. 1. School of Pharmacy, Curtin Health Innovation Research Institute, Curtin University of Technology, Perth, Western Australia, Australia; N S Technologies Pty Ltd., Perth, WA 6050, Australia. Electronic address: c.desai@curtin.edu.au. 2. Burn Injury Research Unit, School of Surgery, University of Western Australia, Burn Service of Western Australia, Royal Perth Hospital, Perth, WA, Australia. 3. Anaesthesiology in Pharmacology, University of Western Australia, MRF Building, RPH, Perth, WA 6847, Australia. 4. School of Pharmacy, Curtin Health Innovation Research Institute, Curtin University of Technology, Perth, Western Australia, Australia. 5. N S Technologies Pty Ltd., Perth, WA 6050, Australia.
Abstract
BACKGROUND: Partial thickness skin graft wounds are painful. Topically applied lidocaine has been used for analgesia in several clinical trials. This study compared the effectiveness of two different formulations of topical local anaesthetic for dressing changes of partial thickness skin graft donor sites. METHODS: A double-blind randomised controlled, pilot trial was conducted in 29 patients undergoing split thickness skin graft surgery. Subjects were randomised to either a 3% lidocaine emulsion formulation "Treatment E" (NOPAYNE™) or a 4% aqueous solution "Treatment A" (Xylocaine™). Subjects received one spray per 3 cm(2) of donor site area followed by up to two further spays as required. Endpoints included pain intensity measured by the numerical rating scale (NRS) up to 1h after dressing change commencement, sting sensation, overall satisfaction and lidocaine plasma concentration. RESULTS: The 60 min pain scores for E and A were 1.3 ± 0.3 (mean ± SEM) and 1.8 ± 0.4 (p=0.98) respectively. Nearly 90% of patients were very satisfied with their treatment. The mean plasma concentrations of lidocaine for A and E were 0.132 mg/l and 0.040 mg/l respectively (p=0.069). CONCLUSION: The topical local anaesthetic formulations achieved low pain scores during dressing changes. The safety profile was potentially improved with the emulsion formulation of lidocaine.
RCT Entities:
BACKGROUND: Partial thickness skin graft wounds are painful. Topically applied lidocaine has been used for analgesia in several clinical trials. This study compared the effectiveness of two different formulations of topical local anaesthetic for dressing changes of partial thickness skin graft donor sites. METHODS: A double-blind randomised controlled, pilot trial was conducted in 29 patients undergoing split thickness skin graft surgery. Subjects were randomised to either a 3% lidocaine emulsion formulation "Treatment E" (NOPAYNE™) or a 4% aqueous solution "Treatment A" (Xylocaine™). Subjects received one spray per 3 cm(2) of donor site area followed by up to two further spays as required. Endpoints included pain intensity measured by the numerical rating scale (NRS) up to 1h after dressing change commencement, sting sensation, overall satisfaction and lidocaine plasma concentration. RESULTS: The 60 min pain scores for E and A were 1.3 ± 0.3 (mean ± SEM) and 1.8 ± 0.4 (p=0.98) respectively. Nearly 90% of patients were very satisfied with their treatment. The mean plasma concentrations of lidocaine for A and E were 0.132 mg/l and 0.040 mg/l respectively (p=0.069). CONCLUSION: The topical local anaesthetic formulations achieved low pain scores during dressing changes. The safety profile was potentially improved with the emulsion formulation of lidocaine.
Authors: Ralf Baron; Andreas Binder; Rolf Biniek; Stephan Braune; Hartmut Buerkle; Peter Dall; Sueha Demirakca; Rahel Eckardt; Verena Eggers; Ingolf Eichler; Ingo Fietze; Stephan Freys; Andreas Fründ; Lars Garten; Bernhard Gohrbandt; Irene Harth; Wolfgang Hartl; Hans-Jürgen Heppner; Johannes Horter; Ralf Huth; Uwe Janssens; Christine Jungk; Kristin Maria Kaeuper; Paul Kessler; Stefan Kleinschmidt; Matthias Kochanek; Matthias Kumpf; Andreas Meiser; Anika Mueller; Maritta Orth; Christian Putensen; Bernd Roth; Michael Schaefer; Rainhild Schaefers; Peter Schellongowski; Monika Schindler; Reinhard Schmitt; Jens Scholz; Stefan Schroeder; Gerhard Schwarzmann; Claudia Spies; Robert Stingele; Peter Tonner; Uwe Trieschmann; Michael Tryba; Frank Wappler; Christian Waydhas; Bjoern Weiss; Guido Weisshaar Journal: Ger Med Sci Date: 2015-11-12