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

Overview

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.

Full Title of Study: “Effect of Preoperative Acetaminophen-Codeine-Caffeine Combination on Inferior Alveolar Nerve Block Success in Patients With Symptomatic Irreversible Pulpitis: Randomized Double-blind Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: May 2021

Detailed Description

After ensuring eligibility, patients will be given premedication 1hr before treatment,which will be done in single visit. After 1 hour, Pretreatment pain "pain after administration of analgesic or placebo" will be recorded using 0-10 numerical rating scale (NRS) . Local anesthesia will, then, be done through inferior alveolar nerve block using 1.8 ml Mepivacaine. The teeth will be isolated using rubber dam and access cavity will be prepared using #2 high-speed round bur. The patients will be asked to rate their pain on the NRS. The degree of pain during access preparation and/or instrumentation will be recorded. Success will be defined as no pain or mild pain during endodontic access preparation and/or instrumentation. Any pain more than no pain or mild pain will considered a failure. Postoperative pain will be recorded at 6,12,24,and 48 hours. The patients will be instructed to return after 2 days to complete the treatment procedures by placing a permanent restoration.

Interventions

  • Drug: Acetaminophen and codeine and caffeine
    • The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.
  • Drug: Acetaminophen
    • The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
  • Drug: Placebo
    • The patient will receive placebo (starch) 1hour before treatment.

Arms, Groups and Cohorts

  • Experimental: Acetaminophen, codeine,and caffeine
    • Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.
  • Experimental: Acetaminophen
    • Oral single dose of 1000mg acetaminophen.
  • Placebo Comparator: Placebo
    • Maize starch.

Clinical Trial Outcome Measures

Primary Measures

  • Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.
    • Time Frame: During the treatment
    • 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”

Secondary Measures

  • Postoperative pain at 6h
    • Time Frame: 6 hours
    • Will be recorded by 11point NRS 0: reading represents “no pain” 1-3 : readings represent “mild pain” 4-6 : readings represent “moderate pain” 7-10 : readings represent “severe pain”
  • Postoperative pain at 12h
    • Time Frame: 12 hours
    • Will be recorded by 11point NRS 0: reading represents “no pain” 1-3 : readings represent “mild pain” 4-6 : readings represent “moderate pain” 7-10 : readings represent “severe pain”
  • Postoperative pain at 24h
    • Time Frame: 24 hours
    • Will be recorded by 11point NRS 0: reading represents “no pain” 1-3 : readings represent “mild pain” 4-6 : readings represent “moderate pain” 7-10 : readings represent “severe pain”
  • Postoperative pain at 48h
    • Time Frame: 48 hours
    • Will be recorded by 11point NRS 0: reading represents “no pain” 1-3 : readings represent “mild pain” 4-6 : readings represent “moderate pain” 7-10 : readings represent “severe pain”

Participating in This Clinical Trial

Inclusion Criteria

1. Patients aging between 18-50 years old. 2. Patients with mandibular molar with symptomatic irreversible pulpitis. 3. Systemically- healthy patients. 4. Patients who agree to attend for recall appointments and provide a written consent. Exclusion Criteria:

1. Pregnant or lactating female patients. 2. Patients had allergies to any of test medications. 3. Patients had taken analgesics medication within the last 6 hours. 4. Moderate or severe marginal periodontitis i.e. pocket probe>3mm. 5. Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Cairo University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Alaa Mohammed Abdallah Morsi, Post graduate student, Department of Endodontics, Faculty of Dentistry,Cairo University – Cairo University
  • Overall Official(s)
    • Alaa M. Morsi, Principal Investigator, faculty of dentistry Cairo university
  • Overall Contact(s)
    • Alaa M. Morsi, B.D.S, 01092595968, alaa.morsi@dentistry.cu.edu.eg

References

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.

Cohen HP, Cha BY, SpÄngberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3.

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.

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