A randomised, double‐blind, placebo‐controlled study to determine the analgesic efficacy, safety and tolerability of VPX638 administered topically to painful wounds.
New analgesics are needed for painful wounds. Multiple reports suggest that topical sevoflurane may have analgesic effects. This placebo‐controlled randomised trial evaluated the analgesic efficacy and safety of VPX638 (topical sevoflurane). Seventy‐eight participants with painful wounds, were enrol...
| Published in: | Wound Repair & Regeneration Vol. 33; no. 1; pp. 1 - 12 |
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| Main Authors: | , , , , , , , , , , , , , , |
| Format: | research tables/charts randomized controlled trial Journal Article |
| Published: |
Wiley-Blackwell
Jan/Feb2025
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=183688096&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 183688096 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 10671927 DPV jtl: Wound Repair & Regeneration issn: 10671927 maglogo: Y pubinfo: dt: Jan/Feb2025 vid: 33 iid: 1 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 183688096 183688096 183688096 10.1111/wrr.70008 183688096 ppf: 1 ppct: 11 formats: fmt: – @attributes: type: T – @attributes: type: C – @attributes: type: P tig: atl: A randomised, double‐blind, placebo‐controlled study to determine the analgesic efficacy, safety and tolerability of VPX638 administered topically to painful wounds. aug: au: Golledge, Jonathan Parra, Sergio Aldons, Pat M. Frescos, Nicoletta Iseli, Rebecca K. Pardey, Toni M. Pretorius, Casper F. Shum, Omar R. Yates, Paul A. Bascoul, Cécile B. Doolittle, Dannette K. Rege, Ajay A. Thanawala, Vaidehi J. Giles, Heather Woodward, Michael C. affil: Queensland Research Centre for Peripheral Vascular Disease, James Cook University and Townsville University Hospital and Australian Institute of Tropical Health and Medicine, Townsville Queensland,, Australia sug: subj: Sevoflurane Administration and Dosage Administration, Topical Wounds, Chronic Drug Therapy Wounds, Chronic Complications Wound Healing Drug Effects Pain Drug Therapy Treatment Outcomes Human Funding Source Male Female Middle Age Aged Aged, 80 and Over Australia Randomized Controlled Trials Random Assignment Double-Blind Studies Placebos Multicenter Studies Descriptive Statistics Comparative Studies Analgesics, Opioid Therapeutic Use Pain Measurement Questionnaires Middle Aged: 45-64 years Aged: 65+ years Aged, 80 & over Male Female ab: New analgesics are needed for painful wounds. Multiple reports suggest that topical sevoflurane may have analgesic effects. This placebo‐controlled randomised trial evaluated the analgesic efficacy and safety of VPX638 (topical sevoflurane). Seventy‐eight participants with painful wounds, were enrolled at eight Australian centres and randomly allocated to receive 2 × 5 mL of VPX638 (N = 39) or placebo (N = 40) during one wound dressing change. Numerical pain rating scores and use of opioids were recorded for 24 h. The primary endpoint was pain during wound cleaning, secondary endpoints evaluated pain for 24 h after drug application and opioids use. There was no significant difference in mean pain scores during wound cleaning between VPX638 and placebo (0.854; p = 0.23). The mean differences in summed pain intensity difference from baseline suggested VPX638 provided greater analgesia compared to placebo over 8 h (p < 0.02), 12 h (p < 0.01) and 24 h (p < 0.05) and significantly longer duration of analgesia, 24.3 h for VPX638 versus 7.1 h for placebo (p < 0.01). In the 24 h after drug administration, participants receiving VPX638 had a 50% decrease in opioid use over 24 h compared with placebo. VPX638 appeared safe and well‐tolerated. In conclusion, this small placebo‐controlled randomised trial suggested that VPX638 provides analgesia and is opioid‐sparing for up to 24 h after wound cleaning. It supports the need for further evaluation of the benefit of VPX638 as a topical analgesic for painful wounds. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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