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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT04202406
Collaborator
(none)
69
1
3
6
11.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Prevention
Official 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
Actual Study Start Date :
Jan 9, 2021
Actual Primary Completion Date :
May 10, 2021
Actual Study Completion Date :
Jul 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Acetaminophen, codeine,and caffeine

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

Drug: Acetaminophen 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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of dentistry Cairo university Giza Non-US/Non-Canadian Egypt 11433

Sponsors and Collaborators

  • Cairo University

Investigators

  • Principal Investigator: Alaa M. Morsi, Cairo University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Alaa Mohammed Abdallah Morsi, Post graduate student, Department of Endodontics, Faculty of Dentistry,Cairo University, Cairo University
ClinicalTrials.gov Identifier:
NCT04202406
Other Study ID Numbers:
  • CEBD-CU-2019-03-13
First Posted:
Dec 17, 2019
Last Update Posted:
Jul 21, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Alaa Mohammed Abdallah Morsi, Post graduate student, Department of Endodontics, Faculty of Dentistry,Cairo University, Cairo University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 21, 2021