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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04202406
Enrollment
69
Registered
2019-12-17
Start date
2021-01-09
Completion date
2021-07-11
Last updated
2021-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Symptomatic Irreversible Pulpitis

Keywords

Postoperative pain, Paracetamol, Placebo, Single visit root canal treatment

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.

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.

Interventions

DRUGAcetaminophen 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.

DRUGAcetaminophen

The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.

DRUGPlacebo

The patient will receive placebo (starch) 1hour before treatment.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.During the treatmentWill 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026