ASA 1 and 2 patients admitted for Day case surgery- assessment of cannulation pain after topical anaesthetic applications.
Conditions
Interventions
Trade Name: Rapydan 70 mg/70 mg medicated plaster
Product Name: RAPYDAN
Pharmaceutical Form: Medicated plaster
INN or Proposed INN: Lignocaine
Other descriptive name: Lidocaine
Concentration unit: mg
Sponsors
Leeds Teaching Hospital NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Written informed consent • Consenting Male and female adults 18-65 yrs • Day case surgical patients • ASA I & II patients • Viable veins on the dorsum of non-dominant hand • Operating list does not normally use topical or local preparations for cannulation Exclusion criteria • Pregnant / lactating females • Visual, hearing or language communication problems • Broken skin/ wound on the dorsum of the hand • Known anaphylaxis • History of allergy to local anaesthetics • History of Meth-hemoglobinemia • Patients on anti-epileptic medication • Patients on anti-arrhythmic medication (quinidine, disopyramide, tocainide, mexiletine and amiodarone) • Patients on Prescription analgesics • Participation in an interventional research study within the last 3 months Are the trial subjects under 18? Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1)Known anaphylaxis to Local Anaesthetics (to prevent occurrence of allergic reactions) 2)Hearing or visual impairment(which would make communication difficult and may be unable to get a valid consent) 3)Prescription analgesics (as these would increase the threshold for pain and can invalidate results and scores) 4)Any other condition which would contradict trial participation( to prevent drug interactions upon systemic absortion and prevent methaemoglobinaemia) e.g anti-arrhythmic medications, congenital enzyme abnormalities 5)Pregnant or lactating females (to prevent any adverse reactions in the mother or the unborn baby)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is there a clinical difference between Rapydan and Ametop in providing pain relief for venous cannulation?;Secondary Objective: Safety profile. Patient satisfaction. Vasoconstriction of the vein.;Primary end point(s): Efficacy of Rapydan compared to Ametop | — |
Countries
United Kingdom
Outcome results
None listed