Evaluation of the effect of gabapentin in the treatment of disgusia following ear surgery
Design
This study is a randomized clinical trial study with balanced block randomization method with a sample number of 170 cases, which is performed as a double-blind.
Settings and conduct
Patients with middle ear diseases who undergo surgery at Taleghani Hospital are evaluated for taste disorders with a questionnaire. The study is a double blind study.
Participants/Inclusion and exclusion criteria
Inclusion : All patients who have undergone surgery to treat a middle ear infection.
Exclusion: History of systemic and peripheral diseases, psychiatric illness, metabolic disease, or a history of dysgeusia
Intervention groups
case: Patients in the intervention group receive a daily dose of 600 mg of gabapentin capsules (Razak Pharmaceutical Company) for 3 months.
Control: Patients in the control group receive a placebo similar to the main drug.
Main outcome variables
taste؛
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200525047566N1
Registration date:2021-08-08, 1400/05/17
Registration timing:registered_while_recruiting
Last update:2021-08-08, 1400/05/17
Update count:0
Registration date
2021-08-08, 1400/05/17
Registrant information
Name
Arash Esmaeili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4422 3777
Email address
arash.esmaeili@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-21, 1399/05/31
Expected recruitment end date
2022-02-19, 1400/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Prevalence of Dysgeusia After Surgical Treatment of Chronic Otitis Media and Evaluation of Therapeutic Effect of Gabapentin
Public title
The effect of gabapentin on Dysgeusia after ear surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have undergone surgery to treat a chronic otitis media are questioned for the complication of Dysgeusia.
Exclusion criteria:
history of systemic diseases
central and peripheral neurological diseases
psychiatric illness
metabolic disease
history of Dysgeusia
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
171
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, we will use the balanced block randomization method. Blocking is used in order to balance the number of samples assigned to each group.
The size of all the blocks is equal and we will have 10 blocks of 6 cases
(including 3 participants in an intervention group and 3 participants in the control group) in this trial.
Software allocation Random is used for randomization. This software capable to generate random sequences by block generation method.
For hiding we use concealment allocation in a way that before the individual is assigned, the assigned group is not specified. In this method, each of the random sequences created on a cards are placed in the closed envelopes. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the envelopes are glued and placed inside a box, respectively.
At the time of registration of participants, based on the order of entry of the eligible participants in the study, one of the closed envelopes will be opened and the assigned group of the participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
To reduce bias or bias related to the intervention and evaluation of the consequences, the method of double blind is used. In this method, the trial is planned in such a way that the participants do not know which of the two control or intervention groups he/she belongs to. Random blocks are also prepared by a person who is not involved in the treatment and are given to the therapist without informing the therapist.