Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

NCT02601911 | Completed Phase 2 DMC

• 1 other identifier: AzadUMS P/66/D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers including criteria, 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 applying the injection. All patients will receive standard Inferior Alveolar Nerve Block injection . Patients with no lip numbness and positive responses to cold and electric pulp tests would be excluded from the study. Endodontic access preparation will be initiated 15 minutes after Inferior Alveolar Nerve Block injection. Pain during treatment will be recorded using a Heft parker Visual Analog Scale(VAS). Success will be considered as no or mild pain (VAS≤54) during caries/dentin removal, access cavity preparation and working lengths measurements. Data will be analysed using Mann-U-Whitney and Kruskal-wallis tests.

Conditions

Irreversible Pulpitis

Keywords

Failure; Injection; Ketorolac; Premedication

Outcome Measures

Primary Outcomes (1)

• Pain rate using Visual Analog Scale (VAS) form

  Pain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form.

  45 minutes

Study Arms (3)

Ketorolac tromethanine

ACTIVE COMPARATOR

This group will receive a caplet including10 mg Ketorolac tromethamine 45 minutes before applying infra alveolar nerve block injection.

Drug: Ketorolac Tromethamine

Acetaminophen

ACTIVE COMPARATOR

This group receive a caplet including10 mg Ketorolac tromethamine/ 1000 mg Acetaminophen, before applying the injection.

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

This group receive a caplet including placebo, before applying the injection.

Other: Placebo

Interventions

Ketorolac Tromethamine DRUG

10 mg Ketorolac tromethamine is applied 45 minutes before the injection.

Also known as: Toradol

Ketorolac tromethanine

Acetaminophen DRUG

10 mg Ketorolac tromethamine/ 1000mg Acetaminophen application before injection.

Also known as: non

Acetaminophen

Placebo OTHER

This group receive the caplet including placebo 45 minutes before the injection.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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
• understand and sign the VAS and consent forms

Sponsors & Collaborators

• Azad University of Medical Sciences: lead

Study Sites (1)

Dental Branch, AZad UMS

Tehran, Tehran Province, Iran

Location

MeSH Terms

Interventions

Ketorolac Tromethamine; Acetaminophen

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nahid Mohammadzadeh Akhlaghi, DDS, MDS

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 27, 2015
• First Posted: November 11, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Locations

IR (1)