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Effect of Premedication on Success of Inferior Alveolar Nerve Block Injection

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02601911
Enrollment
60
Registered
2015-11-11
Start date
2015-09-30
Completion date
2016-06-30
Last updated
2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irreversible Pulpitis

Keywords

Failure, Injection, Ketorolac, Premedication

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.

Detailed 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.

Interventions

DRUGKetorolac Tromethamine

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

DRUGAcetaminophen

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

OTHERPlacebo

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

Sponsors

Azad University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Pain rate using Visual Analog Scale (VAS) form45 minutesPain during caries and dentin removal , access cavity preparation and working lengths measurements using VAS form.

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026