Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis

NCT04961268 | Completed

• 1 other identifier: Alfarabi
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Aim: The purpose of this prospective, randomized, double-blind, controlled study was to compare the preoperative oral tramadol medication with ibuprofen and acetaminophen on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methodology: The study included five study groups, each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar. The patients received identically appearing capsules containing either tramadol 50 mg, tramadol 100 mg, ibuprofen 600 mg, ibuprofen 600 mg/acetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB. Endodontic access was begun 15 min after completion of the IANB, and all patients used for data analysis had profound lip numbness. The IANB success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The data were analysed using chi-square χ2 and Kruskal-Wallis tests.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

anaesthesia; endodontics; inferior alveolar nerve block; NSAIDs; tramadol

Outcome Measures

Primary Outcomes (1)

• Pain Measurement as Assessed on a Heft-Parker 170 mm Visual Analog Scale

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

Tramadol 50

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient received tramadol 50 mg in opaque yellow size "000" capsules.

Drug: TraMADol 50 Mg Oral Tablet

Tramadol 100

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient received tramadol 100 mg in opaque yellow size "000" capsules.

Drug: Tramadol 100 MG Oral Tablet

Ibuprofen

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient received ibuprofen 600 mg in opaque yellow size "000" capsules.

Drug: Ibuprofen 600Mg Tab

Ibuprofen/acetaminophen

ACTIVE COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient received ibuprofen 600 mg/acetaminophen 1000 mg in opaque yellow size "000" capsules.

Drug: ibuprofen 600 mg/acetaminophen 1000 mg

Placebo

PLACEBO COMPARATOR

Before the inferior alveolar nerve block injection by 60 minutes, the patient received Placebo in opaque yellow size "000" capsules.

Drug: Placebo

Interventions

TraMADol 50 Mg Oral Tablet DRUG

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

Also known as: TRAMAL

Tramadol 50

Tramadol 100 MG Oral Tablet DRUG

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

Also known as: TRAMAL

Tramadol 100

Ibuprofen 600Mg Tab DRUG

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

Also known as: IBUPROFEN

Ibuprofen

ibuprofen 600 mg/acetaminophen 1000 mg DRUG

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

Also known as: IBUPROFEN/PANADOL

Ibuprofen/acetaminophen

Placebo DRUG

The patients were 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 (9)

• Argueta-Figueroa L, Arzate-Sosa G, Mendieta-Zeron H. Anesthetic efficacy of articaine for inferior alveolar nerve blocks in patients with symptomatic versus asymptomatic irreversible pulpitis. Gen Dent. 2012 Jan-Feb;60(1):e39-43.

  PMID: 22313992 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

• 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

• Aggarwal V, Singla M, Miglani S. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial. J Oral Facial Pain Headache. 2017 Spring;31(2):124-128. doi: 10.11607/ofph.1642.

  PMID: 28437508 BACKGROUND

• Fowler S, Drum M, Reader A, Beck M. Anesthetic Success of an Inferior Alveolar Nerve Block and Supplemental Articaine Buccal Infiltration for Molars and Premolars in Patients with Symptomatic Irreversible Pulpitis. J Endod. 2016 Mar;42(3):390-2. doi: 10.1016/j.joen.2015.12.025. Epub 2016 Jan 28.

  PMID: 26831048 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

• Lapidus D, Goldberg J, Hobbs EH, Ram S, Clark GT, Enciso R. Effect of premedication to provide analgesia as a supplement to inferior alveolar nerve block in patients with irreversible pulpitis. J Am Dent Assoc. 2016 Jun;147(6):427-37. doi: 10.1016/j.adaj.2016.01.006. Epub 2016 Mar 4.

  PMID: 26952243 BACKGROUND

• Rogers BS, Botero TM, McDonald NJ, Gardner RJ, Peters MC. Efficacy of articaine versus lidocaine as a supplemental buccal infiltration in mandibular molars with irreversible pulpitis: a prospective, randomized, double-blind study. J Endod. 2014 Jun;40(6):753-8. doi: 10.1016/j.joen.2013.12.022. Epub 2014 Feb 8.

  PMID: 24862701 BACKGROUND

• Fullmer S, Drum M, Reader A, Nusstein J, Beck M. Effect of preoperative acetaminophen/hydrocodone on the efficacy of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a prospective, randomized, double-blind, placebo-controlled study. J Endod. 2014 Jan;40(1):1-5. doi: 10.1016/j.joen.2013.09.009. Epub 2013 Oct 27.

  PMID: 24331983 BACKGROUND

MeSH Terms

Interventions

Tramadol; Tablets; Ibuprofen; Acetaminophen

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Dimethylamines; Methylamines; Amines; Lipids; Dosage Forms; Pharmaceutical Preparations; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Acetanilides; Anilides; Amides; Aniline Compounds

Study Officials

• Amr M Elnaghy, PhD

  Associate Professor of Endodontics

  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 was randomly allocated a code consists of 2 letters and one number. Only the random numbers identified the medications; thus, the patient and doctor were uninformed of which medication was given to them.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The study included five study groups, each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar. The patients received identically appearing capsules containing either tramadol 50 mg, tramadol 100 mg, ibuprofen 600 mg, ibuprofen 600 mg/acetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB. Endodontic access was begun 15 min after completion of the IANB, and all patients used for data analysis had profound lip numbness. The IANB success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation.

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 14, 2021
• Study Start: June 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: July 19, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: For individual participant data meta-analysis

Locations

SA (1)