management of pain from donor sites in burns subjects undergoing skin grafts
Conditions
Interventions
Product Name: PSD502
Product Code: PSD502
Pharmaceutical Form: Cutaneous spray*
INN or Proposed INN: LIDOCAINE
CAS Number: 137-58-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
PLETHORA SOLUTIONS LIMITED
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be considered suitable for the study if he or she fulfils all of the following criteria: 1. Male or female ASA class I/II (American Society of Anesthesiologists class I or II, see Appendix IV of the protocol) with burns that require skin grafts. 2. Scheduled to have skin grafted from one or two donor sites. 3. Aged 18 - 75 years inclusive. 4. Normal clinical examination (except for burns). 5. Able to understand and complete the VAPS form. 6. Willing and able to provide written informed consent. Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A subject who fulfils any of the following criteria is excluded from the study: 1. Skin grafted from three or more donor sites. 2. Receipt of another investigational product within 3 months prior to screening. 3. Known hypersensitivity to amide-type local anaesthetics, or other known drug allergies. 4. Requirement for amide local anaesthetics pre- or intra-operatively. Should a subject receive amide local anaesthetics pre- or intra-operatively, they must be withdrawn. 5. Clinically relevant abnormality on ECG, in the opinion of the investigator, such as prolonged QTc. 6. History of alcohol or drug abuse. 7. Clinically significant abnormal blood biochemistry or haematology, in the opinion of the investigator. 8. History of psychiatric illness, from vulnerable groups, or have learning difficulties. 9. Female subjects who are pregnant or lactating. 10. Sexually active females who are of child-bearing potential (<2 years post menopausal) and not using a reliable method of contraception (oral, injectable or implantable contraceptives, barrier methods of contraception, or surgically sterile). 11. Currently taking, or have taken within the 2 weeks prior to screening, any of the following medications: acetanilide, aniline dyes, benzocaine, chloroquine, dapsone, metoclopramide, naphthalene, nitrates (including glyceryl trinitrate), nitrites, nitroprusside, pamaquine, para-aminosalicylic acid, phenacetin, phenobarbital, phenytoin, primaquine, quinine, or sulfonamides. 12. Have taken paracetamol within 2 hours of receiving study treatment. 13. Known liver disease, known renal disease or heart failure. Additional Exclusion Criterion for Part 2 14. Size of donor site(s) exceeds the area that can be covered by the maximum dose (See Appendix V of the protocol).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary Objective To evaluate and compare the efficacy of PSD502 with placebo in relieving pain, as assessed by visual analogue pain scale (VAPS), from skin graft donor sites. ;Secondary Objective: Secondary Objectives • To evaluate the safety and tolerability of PSD502 applied to skin graft donor sites. • To characterise the preliminary pharmacokinetics of PSD502. • To evaluate and compare the effect of PSD502 with placebo on morphine requirements. ;Primary end point(s): Primary efficacy variable: The primary efficacy variable is pain at the donor site as measured by the mean VAPS score in the first 4 hours after the first administration of study medication in Part 2 of the study. Secondary efficacy variables: The secondary efficacy variables, recorded in Part 2 of the study, will be: • the mean VAPS score over the 4-hour period after administration of the second dose of study medication • the mean VAPS score over the 4-hour period after administration of the third dose of study medication • the mean VAPS score over the 4-hour period after administration of the fourth dose of study medication • the duration of morphine requirement • the total dose of morphine received in the first 24 hours after dosing. Criteria for evaluation of safety: Safety will be assessed by means of adverse events, laboratory evaluations, vital signs, 12-lead ECG and physical examination in the 48 hours after the first dose of study medication. | — |
Countries
United Kingdom
Outcome results
None listed