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

Cairo University (CU)

Status: Completed

Conditions: Symptomatic Irreversible Pulpitis

Treatments: Drug: Acetaminophen; Drug: Acetaminophen and codeine and caffeine; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04202406

CEBD-CU-2019-03-13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 69 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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69 participants in 3 patient groups, including a placebo group

Acetaminophen, codeine,and caffeine

Experimental group

Description:

Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.

Treatment:

Drug: Acetaminophen and codeine and caffeine

Acetaminophen

Experimental group

Description:

Oral single dose of 1000mg acetaminophen.

Treatment:

Drug: Acetaminophen

Placebo

Placebo Comparator group

Description:

Maize starch.

Treatment:

Drug: Placebo