Comparison of the Effect of Diclofenac Sodium and Ketorolac on Post Endodontic Pain in Mandibular first Molars with Symptomatic Irreversible Pulpitis
Design
A randomised, double blinded clinical trial with a parallel group design of 45 patients. A random number table was used for randomization.
Settings and conduct
A number of 45 patients with inclusion criteria who referred to Alborz Dental Clinic of Urmia or Dental Office.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 60 years with mandibular first molars with irreversible pulpitis require endodontic treatment.
Non-entry conditions: Any drug interactions with the drugs in this study and a history of systemic diseases
Intervention groups
Intervention group 1: Patients receiving diclofenac sodium
Intervention group 2: Patients receiving ketorolac
Control group: patients receiving placebo
Main outcome variables
Pain intensity, duration of analgesia
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180513039638N1
Registration date:2021-04-04, 1400/01/15
Registration timing:prospective
Last update:2021-04-04, 1400/01/15
Update count:0
Registration date
2021-04-04, 1400/01/15
Registrant information
Name
Amir Ardalan Abdollahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3336 3600
Email address
abdollahi.am@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-08, 1400/01/19
Expected recruitment end date
2021-08-10, 1400/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparasion of the Effect of Diclofenac Sodium and Ketorolak on Post Endodontic Pain in Mandibular first Molars with Symptomatic Irreversible Pulpitis
Public title
Evaluation of analgesic effects of diclofenac sodium and ketorolac in root canal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patient who requires root canal treatment of the first mandibular molars with irreversible pulpitis Between the ages of 18 and 60
Exclusion criteria:
Being in late pregnancy or breastfeeding
Having Asthma or any allergies to diclofenac sodium or ketorolac
History of gastrointestinal diseases such as stomach ulcers
History of Bleeding disorders
Intention to perform heart bypass surgery after receiving medication
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple, individual way with the help of Random.org and by the assistant. Patients were divided into three treatment groups using random numbers generated by Random.org.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher delivers painkillers and placebo in three sealed envelopes to the clinician. Study participants receive one of the medications after randomization by an assistant.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Alborz St., Alborz Dental Clinic
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2020-12-01, 1399/09/11
Ethics committee reference number
IR.UMSU.REC.1399.268
Health conditions studied
1
Description of health condition studied
pain in tooth
ICD-10 code
K04.4
ICD-10 code description
Acute apical periodontitis of pulpal origin
Primary outcomes
1
Description
Intensity of pain
Timepoint
Measurement of patient's toothache immediately before treatment and at 6, 12 and 24 hours after treatment
Method of measurement
Visual Analog Scale Pain Assessment Form
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, diclofenac sodium 100 mg analgesic made by Shafa is taken as an oral tablet and a single dose before starting treatment.
Category
Treatment - Drugs
2
Description
In this group, Ketorolac 10 mg analgesic made by Iran Hormone is used as an oral tablet and a single dose before starting treatment.
Category
Treatment - Drugs
3
Description
Control group: This group receives a placebo drug made from starch powder by a pharmacist consultant as a single oral tablet before treatment.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Alborz Dental Clinic of Urmia
Full name of responsible person
Amir Ardalan Abdollahi
Street address
Alborz Street
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
Abdollahi.am@umsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Alborz Street
City
Urmia
Province
West Azarbaijan
Postal code
571478334
Phone
+98 44 3223 4897
Email
Abdollahi.am@umsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?