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Completed

NCT Number: NCT04202406

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of dentistry Cairo university

Giza, Non-US/Non-Canadian, 11433, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aging between 18-50 years old.
  • Patients with mandibular molar with symptomatic irreversible pulpitis.
  • Systemically- healthy patients.
  • Patients who agree to attend for recall appointments and provide a written consent.

Exclusion criteria

  • Pregnant or lactating female patients.
  • Patients had allergies to any of test medications.
  • Patients had taken analgesics medication within the last 6 hours.
  • Moderate or severe marginal periodontitis i.e. pocket probe>3mm.
  • Non-restorable teeth, teeth with necrotic pulp, pulp polyp, tooth tender to percussion, root resorption or root canal calcification, periapical disease

Treatment and study plan

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.

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.

Primary outcomes

  1. Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.

    Time frame: 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"

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 17, 2019
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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