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

Phase 2

Completed

• Conditions: Irreversible Pulpitis
• Interventions: Drug: Placebo; Drug: Ketorolac tromethamine; Drug: Acetaminophen

• Registration Number: NCT02614118
• Lead Sponsor: Azad University of Medical Sciences

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 Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-17
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	placebo 45 minutes before root canal treatment
Acetaminphen & Ketorolac tromethamine	Acetaminophen	1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment
Ketorolac tromethanine	Ketorolac tromethamine	10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment
Acetaminphen & Ketorolac tromethamine	Ketorolac tromethamine	1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment

Primary Outcome Measures

Name	Time	Method
Pain rate change based on visual analog scale(VAS) form	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.

Trial Locations

Locations (1)

Dental Branch, AZad UMS; 🇮🇷 Tehran, Iran, Islamic Republic of