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

N/ACompletedNCT04202406

Cairo University69 enrolled

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.

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. The patients will be instructed to return after 2 days to complete the treatment procedures.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Symptomatic Irreversible Pulpitis

Interventions

Acetaminophen and codeine and caffeineDRUG

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

AcetaminophenDRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Faculty of dentistry Cairo university

Giza, Non-US/Non-Canadian, Egypt

Outcomes

Primary Outcomes

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"

Time frame: During the treatment

Data from ClinicalTrials.gov

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