Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 12/15/2019 |
| Estimated Enrollment Submitted: | 12/15/2019 |
| First Posted: | 12/16/2019 |
| Last Update Submitted: | 07/12/2020 |
| Last Update Posted: | 07/13/2020 |
| Actual Study Start Date: | 11/30/2020 |
| Estimated Primary Completion Date: | 04/30/2021 |
| Estimated Study Completion Date: | 09/30/2021 |
Condition or disease
Intervention/treatment
Drug: Acetaminophen, codeine,and caffeine
Drug: Acetaminophen
Drug: Placebo
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Acetaminophen, codeine,and caffeine Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine. | Drug: Acetaminophen, codeine,and caffeine The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment. |
| 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. |
| Placebo Comparator: Placebo Maize starch. | Drug: Placebo The patient will receive placebo (starch) 1hour before treatment. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation. [During the treatment]
Secondary Outcome Measures
1. Postoperative pain at 6h [6 hours]
2. Postoperative pain at 12h [12 hours]
3. Postoperative pain at 24h [24 hours]
4. Postoperative pain at 48h [48 hours]
