NCT02614118

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 25, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

November 19, 2015

Last Update Submit

September 17, 2016

Conditions

Irreversible Pulpitis

Keywords

Endodontic treatmentnon steroidpainpre medication

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Ketorolac tromethanine

ACTIVE COMPARATOR

10 mg oral Ketorolac tromethanine 45 minutes before root canal treatment

Drug: Ketorolac tromethamine

Acetaminphen & Ketorolac tromethamine

ACTIVE COMPARATOR

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

Drug: Ketorolac tromethamineDrug: Acetaminophen

Placebo

PLACEBO COMPARATOR

placebo 45 minutes before root canal treatment

Drug: Placebo

Interventions

Ketorolac tromethamineDRUG

10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment

Also known as: Toradol
Acetaminphen & Ketorolac tromethamineKetorolac tromethanine
AcetaminophenDRUG

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

Also known as: Tylenol
Acetaminphen & Ketorolac tromethamine
PlaceboDRUG

placebo 45 minutes before root canal treatment

Also known as: disambiguation
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dental Branch, AZad UMS

Tehran, Tehran Province, Iran

Location

MeSH Terms

Conditions

Pain

Interventions

Ketorolac TromethamineAcetaminophen

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Nahid Mohammadzadeh Akhlaghi, DDS,MDS

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 25, 2015

Study Start

September 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

IR(1)