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

Cairo University (CU) logo

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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