Premedication Efficacy of Oral Ketorolac and Ketorolac/ Acetaminophen on Post Endodontic Treatment Pain
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Pain rate change based on visual analog scale(VAS) form
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Not provided
Arms & Interventions
Ketorolac tromethanine
10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment
Intervention: Ketorolac tromethamine (Drug)
Acetaminphen & Ketorolac tromethamine
1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment
Intervention: Ketorolac tromethamine (Drug)
Acetaminphen & Ketorolac tromethamine
1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment
Intervention: Acetaminophen (Drug)
Placebo
placebo 45 minutes before root canal treatment
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Pain rate change based on visual analog scale(VAS) form
Time Frame: 6,12,24,and 48 hour intervals
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Nahid Mohammadzadeh Akhlaghi
Associate Professor
Azad University of Medical Sciences