Safty and efficacy ot Ketamin mouthwash for Mucositis treatment
Design
Double blind randomized controlled trial
Settings and conduct
Childrenn admitted to oncology ward with Mucositis grade 3 or 4. They divided into 2 group. Case group who recieved Ketamin mouthwash. Control group recieved normal salin mouthwash
Participants/Inclusion and exclusion criteria
Children abive 7 years old with chemotherapy induced Mucositis
Intervention groups
Rinsing Ketamin mouthwash 20mg/ ml 3 times a day in case group and normal salin in control group
Main outcome variables
Muvositus grading, Pain severity, Oal tolerance, Onset of effect. Duration of effect
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201218049750N1
Registration date:2020-12-23, 1399/10/03
Registration timing:retrospective
Last update:2020-12-23, 1399/10/03
Update count:0
Registration date
2020-12-23, 1399/10/03
Registrant information
Name
Fatemeh Malek
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7021
Email address
fmalek@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-03-23, 1398/01/03
Expected recruitment end date
2020-08-24, 1399/06/03
Actual recruitment start date
2019-05-22, 1398/03/01
Actual recruitment end date
2019-07-23, 1398/05/01
Trial completion date
2019-07-23, 1398/05/01
Scientific title
Double blind Comparision study on safty ang efficacy of Ketamin mouthwash in children above 7 years old with chemotherapy induced Mucositis
Public title
Ketamin mouthwash for Mucositus treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children above 7 years old with high grade Mucositus
Exclusion criteria:
History of psychosis,
History of seizure
History of allergy to ketamin
Age
From 7 years old to 14 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation. A number of envelopes equal to the size of the sample size were prepared. Groups are divided into two categories A and B. Another person writes the letter A on the half erasers and the letter B on the other half. Take each envelope and receive A or B according to its classification
Blinding (investigator's opinion)
Double blinded
Blinding description
Phamacology specialist prepared mouthwash. Each mouthwash encoded. Pharmacologist is the only person who aware of mouthwash containing. Mouthwashe will taken by patient. At the end of trial , codes will be decrypted.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee in Research of Children's Health Research Institute - Shahid Beheshti University of