Ketamine hydrochloride is a well known general anesthetic. Low dose or sub-anesthetic doses of ketamine have been used effectively as either a primary analgesic or analgesic adjuvant in a variety of pain syndromes. The purpose of this study is to compare the effect of preoperative administration of oral ketamine, ibuprofen, and placebo in managing postendodontic pain. In this clinical trial, 51 patients with irreversible pulpitis are randomly assigned into 3 groups to receive, in a double-blind manner, a single dose of oral ketamine 0.5mg/kg, 600mg of ibuprofen, or placebo. Treatment is completed in one visit. Patients will record their pain levels on a visual analog scale, before and at 2, 4, 8, 12 and 24h after treatment.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201009054697N1
Registration date:2010-12-07, 1389/09/16
Registration timing:prospective
Last update:
Update count:0
Registration date
2010-12-07, 1389/09/16
Registrant information
Name
Ashkan Vakilzadeh
Name of organization / entity
School of Dentistry (Isfahan University of Medical Sciences and Islamic Azad University Khorasgan)
Country
Iran (Islamic Republic of)
Phone
+98 21 2621 4610
Email address
ashkanvakilzadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
School of Dentistry, Isfahan University of Medical Sciences and School of Dentistry, Islamic Azad University Khorasgan Branch
Expected recruitment start date
2010-12-11, 1389/09/20
Expected recruitment end date
2011-10-12, 1390/07/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Preoperative Oral Ketamine in Comparison with Ibuprofen on Postoperative Endodontic Pain
Public title
Effect of Ketamine on Postendodontic Pain
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patient elects root canal therapy for pain originating from a first or second mandibular molar. 2. The diagnosis of irreversible pulpitis is confirmed by a chief complaint of spontaneous pain and cold test application causing an elevated and lingering pain response. 3. The patient presented with American Society of Anesthesiologists (ASA) I or II medical history. 4. Patient reads and understands questionnaires. 5. Patient reports spontaneous pain above 3cm on a VAS (0-10 cm) in past 24h. 6. Patient provides informed consent.
Exclusion criteria: 1. Younger than 18 yr or older than 65 yr. 2. Analgesic taken within the last 8h. 3. History of allergy to NSAIDs, ketamine or local anesthetics. 4. Current use of drugs contraindicated with NSAIDs or ketamine. 5. History of gastrointestinal (GI) disorders, renal or hepatic disease, hemorrhagic disorders, active asthma, poorly controlled diabetes mellitus, cardiovascular disease, increased ICP, intracranial mass lesions, ophthalmologic disorder or psychiatric disease. 6. The patient is pregnant or nursing. 7. Periradicular pathosis, other than a widened periodontal ligament. 8. No vital coronal pulp tissue on access. 9. Occurrence of any mistake during root canal therapy.
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Dentistry, Islamic Azad University Khorasgan Branch
Street address
University Blvd, Arqavanieh, Jey Street, Isfahan
City
Isfahan
Postal code
Approval date
2007-10-24, 1386/08/02
Ethics committee reference number
23810201852031
Health conditions studied
1
Description of health condition studied
Postoperative Endodontic Pain
ICD-10 code
K08.8, K04
ICD-10 code description
Other specified disorders of teeth and supporting structures - Toothache NOS and Pulpitis: acute
Primary outcomes
1
Description
Pain intensity
Timepoint
Before and at 2, 4, 8, 12 and 24h after treatment
Method of measurement
Visual Analog Scale
Secondary outcomes
1
Description
The need for additional medication
Timepoint
Until 24h after treatment
Method of measurement
Questionnaire
2
Description
Time to first request for rescue analgesic
Timepoint
Until 24h after treatment
Method of measurement
Questionnaire
3
Description
The number of rescue analgesic tablets taken
Timepoint
Until 24h after treatment
Method of measurement
Questionnaire
4
Description
The incidence of side effects
Timepoint
Until 24h after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Oral suspension of ibuprofen, 600 mg, A single dose, 30 minutes before the initiation of treatment, Oral
Category
Prevention
2
Description
Placebo, A single dose, 30 minutes before the initiation of treatment, Oral
Category
Placebo
3
Description
Ketamine hydrochloride, 0.5mg/kg, A single dose, 30 minutes before the initiation of treatment, Oral
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Central Dental Clinic of Isfahan's Oil Industry
Full name of responsible person
Ashkan Vakilzadeh - Dentist (D.D.S.)
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of Dentistry, Islamic Azad University Khorasgan Branch
Full name of responsible person
Abbasali Khademi - Full Professor
Street address
University Blvd, Arqavanieh, Jey Street, Isfahan
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of Dentistry, Islamic Azad University Khorasgan Branch
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences and School of Dentistry, Islamic Aza
Full name of responsible person
Ashkan Vakilzadeh
Position
Dentist (D.D.S.)
Other areas of specialty/work
Street address
Hezarjerib Avenue, Isfahan and University Blvd, Arqavanieh, Jey Street, Isfahan
City
Isfahan
Postal code
Phone
+98 21 2621 4610
Fax
Email
ashkanvakilzadeh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences and School of Dentistry, Islamic Aza
Full name of responsible person
Ashkan Vakilzadeh
Position
Dentist (D.D.S.)
Other areas of specialty/work
Street address
Hezarjerib Avenue, Isfahan and University Blvd, Arqavanieh, Jey Street, Isfahan
City
Isfahan
Postal code
Phone
+98 21 2621 4610
Fax
Email
ashkanvakilzadeh@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Dentistry, Isfahan University of Medical Sciences and School of Dentistry, Islamic Aza
Full name of responsible person
Ashkan Vakilzadeh
Position
Dentist (D.D.S.)
Other areas of specialty/work
Street address
Hezarjerib Avenue, Isfahan and University Blvd, Arqavanieh, Jey Street, Isfahan
City
Isfahan
Postal code
Phone
+98 21 2621 4610
Fax
Email
ashkanvakilzadeh@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)