Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Treatment Pain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers including criteria, are participating. The patients will be divided into 3 groups and will be randomly given one of pre medications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before applying the injection. All patients will receive standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54)with no need to take analgesic. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Detailed Description
-----------------
The aim of this study is premedication efficacy of analgesics on post endodontic pain. Sixty-six healthy adult volunteers with age ranged 18-65, non smoking or any medicine consumption, non pregnant or break feeding who haven't received any analgesic during 24 hours before the treatment, are participating. The patients will be divided into 3 groups and will be randomly given one of premedications including 1) 10 mg Ketorolac, 2) 10 mg Ketorolac plus 1000mg Acetaminophen, and 3)Placebo, 45 minutes before the treatment. All patients will receive a standard root canal treatment. Patients will record their post treatment pain using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) with no need to take analgesic during 6, 12, 24 and 48 hours intervals following the treatment. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Official Title
-----------------
Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain

Conditions
-----------------
Irreversible Pulpitis

Intervention / Treatment
-----------------
* Drug: Ketorolac tromethamine
* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age ranged 18-65 without systemic diseases without any medicine consumption non smoking non pregnant non breast feeding with asymptomatic irreversible pulpitis ( Visual Analog Scale ≤ 54) in one mandibular molar that needs root canal treatment without any medicine consumption or analgesic and sedation who understand and sign the VAS and consent forms. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketorolac tromethanine<br>10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment | Drug: Ketorolac tromethamine<br>* 10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment<br>* Other names: Toradol;|
| Active Comparator: Acetaminphen & Ketorolac tromethamine<br>1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment | Drug: Ketorolac tromethamine<br>* 10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment<br>* Other names: Toradol;Drug: Acetaminophen<br>* 1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.<br>* Other names: Tylenol;|
| Placebo Comparator: Placebo<br>placebo 45 minutes before root canal treatment | Drug: Placebo<br>* placebo 45 minutes before root canal treatment<br>* Other names: disambiguation;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain rate change based on visual analog scale(VAS) form | Each patient receives a VAS form and record his/her pain rate on the VAS form whenever he/she feels any pain during each interval after the treatment. If the patient has to take any analgesic, she/he will record the pain rate on that interval and will not continue filling the forms out on the next intervals. | 6,12,24,and 48 hour intervals | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endodontic treatment, non steroid, pain, pre medication