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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Irreversible Pulpitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketorolac tromethanine

10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment

Group Type ACTIVE_COMPARATOR

Ketorolac tromethamine

Intervention Type DRUG

10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment

Acetaminphen & Ketorolac tromethamine

1000 mg Acetaminophen and 10 mg Ketorolac tromethamine oral 45 minutes before root canal treatment

Group Type ACTIVE_COMPARATOR

Ketorolac tromethamine

Intervention Type DRUG

10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment

Acetaminophen

Intervention Type DRUG

1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.

Placebo

placebo 45 minutes before root canal treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo 45 minutes before root canal treatment

Interventions

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Ketorolac tromethamine

10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment

Intervention Type DRUG

Acetaminophen

1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.

Intervention Type DRUG

Placebo

placebo 45 minutes before root canal treatment

Intervention Type DRUG

Other Intervention Names

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Toradol Tylenol disambiguation

Eligibility Criteria

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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.