Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
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.
The patients will be instructed to return after 2 days to complete the treatment procedures.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Acetaminophen, codeine,and caffeine Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine. |
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.
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Experimental: Acetaminophen Oral single dose of 1000mg acetaminophen. |
Drug: Acetaminophen
The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
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Placebo Comparator: Placebo Maize starch. |
Drug: Placebo
The patient will receive placebo (starch) 1hour before treatment.
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Outcome Measures
Primary Outcome Measures
- Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation. [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"
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients aging between 18-50 years old.
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Patients with mandibular molar with symptomatic irreversible pulpitis.
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Systemically- healthy patients.
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Patients who agree to attend for recall appointments and provide a written consent.
Exclusion Criteria:
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Pregnant or lactating female patients.
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Patients had allergies to any of test medications.
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Patients had taken analgesics medication within the last 6 hours.
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Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
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Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Faculty of dentistry Cairo university | Giza | Non-US/Non-Canadian | Egypt | 11433 |
Sponsors and Collaborators
- Cairo University
Investigators
- Principal Investigator: Alaa M. Morsi, Cairo University
Study Documents (Full-Text)
None provided.More Information
Publications
- Cohen HP, Cha BY, SpÄngberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3.
- 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.
- 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.
- CEBD-CU-2019-03-13