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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Symptomatic Irreversible Pulpitis

Intervention / Treatment
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* Drug: Acetaminophen and codeine and caffeine
* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetaminophen, codeine,and caffeine<br>Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine. | Drug: Acetaminophen and codeine and caffeine<br>* The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.<br>|
| Experimental: Acetaminophen<br>Oral single dose of 1000mg acetaminophen. | Drug: Acetaminophen<br>* The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.<br>|
| Placebo Comparator: Placebo<br>Maize starch. | Drug: Placebo<br>* The patient will receive placebo (starch) 1hour before treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative pain, Paracetamol, Placebo, Single visit root canal treatment