Investigating the effect of preoperative diclofenac suppository on opioid consumption and nausea and vomiting in maxillofacial surgeries
Design
Clinical trial with control group, with parallel group, double blind, randomized, phase 3 on 60 patient. Randomization was done using random number table.
Settings and conduct
setteing: Maxillofacial surgery patients in Shahid Rahnemon hospital operation room,
conduct: Prescribtion of Diclofenac and Glycerin suppository with randomization.
Researcher and patients blinded with randomized prescription of drugs and placebo using random number table by a third person.
Participants/Inclusion and exclusion criteria
inclusion criteria:
intermaxillary fixation (IMF) required for patients after maxillofacial surgeries.
Exclusion criteria:
addiction
heart, liver, kidney and gasterointestinal disease
coaglupathy problemes
pregnancy
Intervention groups
Intervention group: prescribe Diclofenac suppository
Control group: prescribe Glycerin suppository
Main outcome variables
Nausea,
Vomiting,
Opioid consumption dosage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200606047664N1
Registration date:2020-07-12, 1399/04/22
Registration timing:retrospective
Last update:2020-07-12, 1399/04/22
Update count:0
Registration date
2020-07-12, 1399/04/22
Registrant information
Name
seyed mojtaba alavikia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3624 7450
Email address
sm.alavikia@spu.ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-23, 1398/06/01
Expected recruitment end date
2020-02-20, 1398/12/01
Actual recruitment start date
2019-08-23, 1398/06/01
Actual recruitment end date
2020-02-20, 1398/12/01
Trial completion date
2020-02-22, 1398/12/03
Scientific title
The investigating the effect of preoperative diclofenac suppository on opioid consumptiom and nausea and vomiting in maxillofacial surgeries
Public title
Investigating the effect of diclofenac suppository on nausea and vomiting
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients required IMF post maxillofacial surgeries
Exclusion criteria:
pregnancy
coaglupathy disfunction
heart, liver, kidney and gasterointestinal disease history
addiction history
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization,
Personal randomization,
Randomized number table,
Third person for concealment
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher name 30 question sheet "A" and 30 question sheet "B", "A and B" show Diclofenac suppository and Glycerin suppository that only research observer knows. Each patient before operation choose one of the question sheet randomly and refer to one of the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd University of Medical Sciences
Street address
Yazd University of Medical Sciences, Shahid Sadoughi Blvd, Bahonar Square
City
Yazd
Province
Yazd
Postal code
۸۹۱۶۹۷۸۴۷۷
Approval date
2020-02-22, 1398/12/03
Ethics committee reference number
IR.SSU.REC.1398.228
Health conditions studied
1
Description of health condition studied
Nausea and vomiting
ICD-10 code
R11
ICD-10 code description
Nausea and vomiting
Primary outcomes
1
Description
Nausea
Timepoint
after recovery, 6 hours post operation, 12 hours post operation
Method of measurement
According to the questionnaire using symptom of nausea.
2
Description
Vomiting
Timepoint
after recovery, 6 hours post operation, 12 hours post operation
Method of measurement
According to the questionnaire using sign of vomiting.