Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis

NCT04202406 | Completed

• 1 other identifier: CEBD-CU-2019-03-13
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate the effect of preoperative administration of acetaminophen- codeine -caffeine combination on the success of the inferior alveolar nerve block versus bacetaminophen alone or placebo in patients with symptomatic irreversible pulpitis.

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Postoperative pain; Paracetamol; Placebo; Single visit root canal treatment

Outcome Measures

Primary Outcomes (1)

• Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.

  Will be recorded by 11 point NRS consisting of numbers from 0 through 10. 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain" 0: reading represents "no pain" 1-3 : readings represent "mild pain" 4-6 : readings represent "moderate pain" 7-10 : readings represent "severe pain"

  During the treatment

Study Arms (3)

Acetaminophen, codeine,and caffeine

EXPERIMENTAL

Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.

Drug: Acetaminophen and codeine and caffeine

Acetaminophen

EXPERIMENTAL

Oral single dose of 1000mg acetaminophen.

Drug: Acetaminophen

Placebo

PLACEBO COMPARATOR

Maize starch.

Drug: Placebo

Interventions

Acetaminophen and codeine and caffeine DRUG

The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.

Acetaminophen, codeine,and caffeine

Acetaminophen DRUG

The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.

Acetaminophen

Placebo DRUG

The patient will receive placebo (starch) 1hour before treatment.

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aging between 18-50 years old.
• Patients with mandibular molar with symptomatic irreversible pulpitis.
• Systemically- healthy patients.
• Patients who agree to attend for recall appointments and provide a written consent.

You may not qualify if:

• Pregnant or lactating female patients.
• Patients had allergies to any of test medications.
• Patients had taken analgesics medication within the last 6 hours.
• Moderate or severe marginal periodontitis i.e. pocket probe\>3mm.
• Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of dentistry Cairo university

Giza, Non-US/Non-Canadian, 11433, Egypt

Location

Related Publications (3)

• Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.

  PMID: 17185119 BACKGROUND

• Cohen HP, Cha BY, Spangberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3. doi: 10.1016/S0099-2399(06)81366-X.

  PMID: 8245762 BACKGROUND

• Simpson M, Drum M, Nusstein J, Reader A, Beck M. Effect of combination of preoperative ibuprofen/acetaminophen on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis. J Endod. 2011 May;37(5):593-7. doi: 10.1016/j.joen.2011.02.015. Epub 2011 Mar 22.

  PMID: 21496654 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Codeine; Caffeine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring

Study Officials

• Alaa M. Morsi

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post graduate student, Department of Endodontics, Faculty of Dentistry,Cairo University

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 17, 2019
• Study Start: January 9, 2021
• Primary Completion: May 10, 2021
• Study Completion: July 11, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

EG (1)