Comparing the effectiveness of post-burn itchy skin treatment with cetirizine or gabapentin
| ISRCTN | ISRCTN10393098 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10393098 |
| Secondary identifying numbers | CHS-Et/M.9-P4.3/2016/2017] |
- Submission date
- 21/05/2022
- Registration date
- 30/05/2022
- Last edited
- 09/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Plain English summary of protocol
Background and study aims
The majority of burn patients suffer from itch (pruritus) during the time of healing and this is a very difficult symptom to treat. The available treatment options have largely not been efficient in treating this disturbing condition. At the Burn Unit of the Korle-Bu Teaching Hospital, patients with post burn itch are often given cetirizine, an antihistamine. This treatment is largely unsatisfactory as many patients do not get relief. New agents for treatment are now available and there is a need to evaluate their efficacy. The aim of this study is to compare the effectiveness cetirizine, gabapentin and a combination of cetirizine and gabapentin in the treatment of pruritus in burn patients. The study will thus score which of the drugs is more effective and will subsequently influence practice in the Unit.
Who can participate?
The study involves burn patients.
What does the study involve?
Participants were asked to provide some personal information such as age, and also, provide information about their condition. They were assigned a random number and were recruited into one of the three arms of the study. The intensity of their itch was scored using a scale. They were also asked a series of questions to assess whether they had sleep disturbance as a result of the itch. Depending on the assigned group, they were given Cetirizine, Gabapentin or a combination of these two drugs. They were reviewed at regular intervals to evaluate the effect of the drug on your itch and to take note of any side effects of the drug. The quality of care was the same for all participants
What are the possible benefits and risks of participating?
There are no direct benefits for participation. However, your participation will contribute to building knowledge on the research topic and ultimately improve management and treatment of post-burn itch.
There are no foreseeable risks associated with participating in this study beyond the documented side effects of the drugs to be administered
Where is the study run from?
National Reconstructive Plastic surgery and Burn Centre (Ghana)
When is the study starting and how long is it expected to run for?
December 2016 to March 2019
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Elliott Arko-Boham, BArko-Boham@ug.edu.gh, sojiar20@gmail.com
Contact information
Principal Investigator
National Reconstructive Plastic surgery and Burn Centre
Korle-Bu Teaching Hospital
P.O Box KB 76
Accra
+233
Ghana
 ORCID ID |
0000-0001-6429-2186 |
|---|---|
| Phone | +233 206 301 118 |
| BArko-Boham@ug.edu.gh |
Study information
| Study design | Interventional randomized double-blind controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effectiveness of post-burn pruritus treatment with cetirizine and gabapentin – a comparative study |
| Study objectives | The effectiveness of gabapentin is greater than the effectiveness of cetirizine against itching in post-burn treatment |
| Ethics approval(s) | Approved 27/04/2017, Ethical and Protocol Review Committee (College of Health Sciences of the University of Ghana, Accra, Ghana; +233 (0) 302 665103; administration@chs.edu.gh), ref: CHS-Et/M.9 - P 4.3/2016-2017 |
| Health condition(s) or problem(s) studied | Treatment of pruritus in post-burn patients |
| 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 box contained 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 6hrs, 14hrs and 22hrs to the study participants recruited into the gabapentin group (group B). They will also receive 100mg vitamin C at the same hours. They, however, were started on the standard 300mg daily dose combined with vitamin C. This dose was increased to 300mg twice daily (600mg total dose) if there was no response to treatment as per VAS on day three, and then increased to the maximum dose of 300mg three times daily (900mg total dose). However, they were maintained on their current dose if there was improvement in symptoms until next review. The Cetirizine-Gabapentin group will be administered a combined dosage of the two medications. Thus, they will be started on 10mg cetirizine combined with 300mg gabapentin as daily dose. The dose of gabapentin was increased to 300mg twice daily when the VAS score did not change whilst the cetirizine dose remained 10mg daily. On the third review day, when the effect of the drug had not increased significantly as per the VAS score, the dosage gabapentin was increased to 300mg three times daily while still maintaining the cetirizine dose of 10mg daily. They also received 100mg vitamin C 8 hourly in combination. This combined treatment was on the assumptions that since both drugs, cetirizine and gabapentin, have different mechanism of action (cetirizine acting peripherally and gabapentin acting centrally), their combined effect should be better than their individual effect. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cetirizine, gabapentin |
| Primary outcome measure | Itch (pain) measured using the visual analogue scale at baseline, day 3, day 7, and day 14 |
| Secondary outcome measures | 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 |
| Overall study start date | 12/12/2016 |
| Completion date | 10/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 63 |
| Total final enrolment | 69 |
| Key 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 |
| Key exclusion criteria | 1. Patients who undergo skin grafting involving 5% TBSA were excluded to maintain ‘pure’ cohort 2. Patients with co-morbidities including skin diseases, diabetes, chronic renal diseases, obstructive jaundice, pregnancy, etc. which by themselves caused itching 3. Patients who were septic 4. Patients with impaired cognitive ability 5. Patients with known hypersensitivity reactions |
| Date of first enrolment | 12/06/2017 |
| Date of final enrolment | 18/12/2018 |
Locations
Countries of recruitment
- Ghana
Study participating centre
Accra
P.O Box KB 77
Ghana
Sponsor information
University/education
P. O. Box MB 429
Accra
+233
Ghana
| Phone | +233 302 238 650 |
|---|---|
| exama@gcps.edu.gh | |
| Website | https://gcps.edu.gh/ |
"ROR" |
https://ror.org/031jxes94 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | Data is available on request from Dr Elliott Arko-Boham by email barko_boham@chs.edu.gh |
Editorial Notes
09/02/2023: The contact was updated.
25/05/2022: Trial's existence confirmed by College of Health Sciences of the University of Ghana.
