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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen, codeine,and caffeine | Experimental | Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine. |
|
| Acetaminophen | Experimental | Oral single dose of 1000mg acetaminophen. |
|
| Placebo | Placebo Comparator | Maize starch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alaa M. Morsi | Cairo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of dentistry Cairo university | Giza | Non-US/Non-Canadian | 11433 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17185119 | Background | 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. | |
| 8245762 | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D003061 | Codeine |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Acetaminophen | Drug | The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment. |
|
| Placebo | Drug | The patient will receive placebo (starch) 1hour before treatment. |
|
| 21496654 | 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. |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D014970 | Xanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |