Comparing the effectiveness of post-burn itchy skin treatment with cetirizine or gabapentin

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2022
INTERVENTION: The study was conducted on patients with burns involving >15% total body surface area at the Burn Unit of KBTH. Severe thermal burn was clinically defined as a thermal burn involving >20% TBSA. Selected patients were randomized into three groups A, B and C. The groups consisted of standard treatment [cetirizine arm (Group A)] and interventional arm [gabapentin (Group B) and combined cetirizine and gabapentin (Group C)]. Patients were randomly allocated to one of the three arms of treatment by simple ballot without replacement. The ballot bo Xcontained 21 sequentially labelled ballot papers of each treatment group (A, B and C), thus containing a total of 63 ballot papers. The concealment was done by first wrapping the drugs in a foil before enveloping it in an opaque (brown) envelope and sealed by stapling. All the foil and envelope were of the same make. The patient’s code and date were written on the back of the envelope. The sealed envelope was then given to the research assistant who was a qualified nurse in the Unit and was instructed on how to administer the drug to the patient. However, she was not told of the drug contained in the envelope. In the case of a missing or damaged drug, the pharmacist who carried out the assignment and could identify the number on the envelope replaced the envelope with the same drug. Cetirizine, 10mg, was administered as a daily dose at 6am combined with 100mg vitamin C to group A participants (cetirizine alone group). The 100mg vitamin C was served again at 14 hours and 22 hours. (The dose of cetirizine remained a daily dose of 10mg throughout the length of the study as this was the standard treatment given at the unit where the study was conducted). At maximum dose, gabapentin was administered as 300mg three times daily at 6h CONDITION: Treatment of pruritus in post‐burn patients ; Skin and Connective Tissue Diseases PRIMARY OUTCOME: Itch (pain) measured using the visual analogue scale at baseline, day 3, day 7, and day 14 SECONDARY OUTCOME: 1. Insomnia measured using the Athens Insomnia Scale at baseline, day 3, day 7, and day 14; 2. Depression measured using the Hospital Anxiety and Depression Scale (HADS) at baseline, day 3, day 7, and day 14 INCLUSION CRITERIA: 1. Patients aged 16–65 years age (assessments with VAS will be difficult in children and the elderly) 2. Patients with burns involving >15% TBSA (TBSA <15 patients are not admitted for treatment. 3. Patients hospitalised for more than 7 days 4. Patients who are proficient in English, Akan or Ga
Epistemonikos ID: 93d3c4452fe51c7b0849ad6de21d397e62545b5e
First added on: Aug 25, 2024