Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

Irreversible Pulpitis Clinical Trial

Official title:

Comparison of Ketorolac and Ketorolac/Acetaminophen on Success of Inferior Alveolar Nerve Block Injection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02601911
• Other study ID #: AzadUMS P/66/D
• Status: Completed
• Phase: Phase 2
• First received: October 27, 2015
• Last updated: September 17, 2016
• Start date: September 2015
• Est. completion date: June 2016

Study information

• Verified date: September 2016
• Source: Azad University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

The aim of this study is effect of premedication on success of inferior alveolar nerve block injection. Sixty healthy adult volunteers with including criteria and with no spontaneous pain, reporting no or mild (Visual analog scale≤54) pain in response to cold testing and electric pulp tester, are participating. The patients will be divided into 3 groups on a random basis and will be randomly given one of the oral 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 Inferior Alveolar Nerve Block injection with one carpule of 4% Articaine with 1:100000 Epinephrine. Patients with no anesthetic sign (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

• understand and sign the VAS and consent forms

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irreversible Pulpitis
• Pulpitis

Intervention

Drug:
• Ketorolac Tromethamine
10 mg Ketorolac tromethamine is applied 45 minutes before the injection.
• Acetaminophen
10 mg Ketorolac tromethamine/ 1000mg Acetaminophen application before injection.

Other:
• Placebo
This group receive the caplet including placebo 45 minutes before the injection.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Dental Branch, AZad UMS	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Azad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No