Effectiveness of Premedication on the Success Rate of Inferior Alveolar Nerve Block

NCT05097768 | Completed DMC

• 1 other identifier: 21-8/1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: The aim of this prospective, double-blind, randomized controlled trial is to compare the effect of oral premedication of dexamethasone, ketorolac, meloxicam, ibuprofen or placebo on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methods: The trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker visual analog scale recordings) on pulpal access or instrumentation.

Conditions

Symptomatic Irreversible Pulpitis

Outcome Measures

Primary Outcomes (1)

• Pain Measurement as it will be assessed on a Heft-Parker 170 mm Visual Analog Scale

  At 60 minutes after receiving the medication or placebo, the participants will be given inferior alveolar nerve block injection. Each patient will be asked for lip numbness every 5 minutes for 15 minutes after inferior alveolar nerve block injection. During the endodontic process, patients will be asked to rate any pain they experienced on a Heft-Parker visual analog scale. The number of millimeters along the scale will be reported. No pain corresponded to 0 mm. Mild pain is defined as greater than 0 mm and less than or equal to 54 mm. Mild pain is the descriptors of "faint", "weak", and "mild pain". Moderate pain is defined as greater than 54 mm and less than 114 mm and includes the descriptor "moderate". Severe pain is defined as equal to or greater than 114 mm up to and including 170 mm. Severe pain includes the descriptors of "strong", "intense", and "maximum possible."

  15 minutes after the inferior alveolar nerve block

Secondary Outcomes (1)

• Postoperative Satisfaction on a 100 mm Visual Analog Scale

  Immediately post-procedure on Day 0

Study Arms (5)

Dexamethasone

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive Dexamethasone 0.5 mg.

Drug: Dexamethasone 0.5mg

Ketorolac

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive ketorolac 10 mg.

Drug: Ketorolac 10 Mg Oral Tablet

Meloxicam

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive meloxicam 7.5 mg.

Drug: Meloxicam 7.5 mg

Ibuprofen

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive ibuprofen 600 mg.

Drug: Ibuprofen 600 mg

Placebo

PLACEBO COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient will receive placebo.

Drug: Placebo

Interventions

Dexamethasone 0.5mg DRUG

The patients will be randomly given the medication by mouth 60 min before administering IANB.

Dexamethasone

Ketorolac 10 Mg Oral Tablet DRUG

The patients will be randomly given the medication by mouth 60 min before administering IANB.

Ketorolac

Meloxicam 7.5 mg DRUG

The patients will be randomly given the medication by mouth 60 min before administering IANB.

Meloxicam

Ibuprofen 600 mg DRUG

The patients will be randomly given the medication by mouth 60 min before administering IANB.

Ibuprofen

Placebo DRUG

The patients will be randomly given the medication by mouth 60 min before administering IANB.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• active pain in a mandibular molar first or/and the second molar
• prolonged response to cold testing
• absence of any periapical radiolucency on periapical radiographs
• vital coronal pulp on access opening
• able to give informed consent

You may not qualify if:

• less than 18 years old
• history of serious medical problems
• used central nervous system depressants or any analgesic medication within the previous 6 hours
• pregnancy
• inability to give informed consent

Sponsors & Collaborators

• Alfarabi Colleges: lead

Study Sites (1)

Vission Colleges

Jeddah, Saudi Arabia

Location

Related Publications (4)

• Nagendrababu V, Pulikkotil SJ, Veettil SK, Teerawattanapong N, Setzer FC. Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis. J Endod. 2018 Jun;44(6):914-922.e2. doi: 10.1016/j.joen.2018.02.017. Epub 2018 Apr 27.

  PMID: 29709297 BACKGROUND

• Pulikkotil SJ, Nagendrababu V, Veettil SK, Jinatongthai P, Setzer FC. Effect of oral premedication on the anaesthetic efficacy of inferior alveolar nerve block in patients with irreversible pulpitis - A systematic review and network meta-analysis of randomized controlled trials. Int Endod J. 2018 Sep;51(9):989-1004. doi: 10.1111/iej.12912. Epub 2018 Mar 24.

  PMID: 29480930 BACKGROUND

• Yadav M, Grewal MS, Grewal S, Deshwal P. Comparison of Preoperative Oral Ketorolac on Anesthetic Efficacy of Inferior Alveolar Nerve Block and Buccal and Lingual Infiltration with Articaine and Lidocaine in Patients with Irreversible Pulpitis: A Prospective, Randomized, Controlled, Double-blind Study. J Endod. 2015 Nov;41(11):1773-7. doi: 10.1016/j.joen.2015.06.008. Epub 2015 Sep 26.

  PMID: 26410153 BACKGROUND

• Aggarwal V, Singla M, Kabi D. Comparative evaluation of effect of preoperative oral medication of ibuprofen and ketorolac on anesthetic efficacy of inferior alveolar nerve block with lidocaine in patients with irreversible pulpitis: a prospective, double-blind, randomized clinical trial. J Endod. 2010 Mar;36(3):375-8. doi: 10.1016/j.joen.2009.11.010.

  PMID: 20171350 BACKGROUND

MeSH Terms

Interventions

Dexamethasone; Ketorolac; Tablets; Meloxicam; Ibuprofen

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; Thiazines; Sulfur Compounds; Organic Chemicals; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Amr M Elnaghy, PhD

  Vision Colleges

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: To blind the experiment, each of the 50 patients in each group will be randomly allocated a code consists of 2 letters and one number. Only the random numbers identify the medications; thus, the patient and doctor are uninformed of which medication will be given to them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Endodontics

Model Details: The trial will include five study groups, each consists of 50 patients who exhibits symptomatic irreversible pulpitis of a mandibular first or second molar. The patients will receive identically appearing capsules containing either dexamethasone 0.5 mg, ketorolac 10 mg, meloxicam 7.5 mg, ibuprofen 600 mg, or placebo by mouth 60 minutes before the administration of an IANB. Endodontic access will begin 15 minutes after completion of the IANB. The IANB success is defined as no or mild pain (Heft Parker visual analog scale recordings) on pulpal access or instrumentation.

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: October 28, 2021
• Study Start: August 15, 2021
• Primary Completion: January 15, 2022
• Study Completion: January 27, 2022
• Last Updated: February 14, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)