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

Primary Purpose

Symptomatic Irreversible Pulpitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Acetaminophen and codeine and caffeine
Acetaminophen
Placebo
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Symptomatic Irreversible Pulpitis focused on measuring Postoperative pain, Paracetamol, Placebo, Single visit root canal treatment

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Faculty of dentistry Cairo university

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Acetaminophen, codeine,and caffeine

Acetaminophen

Placebo

Arm Description

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

Oral single dose of 1000mg acetaminophen.

Maize starch.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 16, 2019
Last Updated
July 15, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04202406
Brief Title
Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 9, 2021 (Actual)
Primary Completion Date
May 10, 2021 (Actual)
Study Completion Date
July 11, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

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

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Irreversible Pulpitis
Keywords
Postoperative pain, Paracetamol, Placebo, Single visit root canal treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetaminophen, codeine,and caffeine
Arm Type
Experimental
Arm Description
Oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine.
Arm Title
Acetaminophen
Arm Type
Experimental
Arm Description
Oral single dose of 1000mg acetaminophen.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maize starch.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen and codeine and caffeine
Intervention Description
The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Intervention Description
The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The patient will receive placebo (starch) 1hour before treatment.
Primary Outcome Measure Information:
Title
Success of mandibular inferior alveolar nerve block anesthesia during access and instrumentation.
Description
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"
Time Frame
During the treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alaa M. Morsi
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of dentistry Cairo university
City
Giza
State/Province
Non-US/Non-Canadian
ZIP/Postal Code
11433
Country
Egypt

12. IPD Sharing Statement

Citations:
PubMed Identifier
17185119
Citation
Ianiro SR, Jeansonne BG, McNeal SF, Eleazer PD. The effect of preoperative acetaminophen or a combination of acetaminophen and Ibuprofen on the success of inferior alveolar nerve block for teeth with irreversible pulpitis. J Endod. 2007 Jan;33(1):11-4. doi: 10.1016/j.joen.2006.09.005.
Results Reference
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PubMed Identifier
8245762
Citation
Cohen HP, Cha BY, Spangberg LS. Endodontic anesthesia in mandibular molars: a clinical study. J Endod. 1993 Jul;19(7):370-3. doi: 10.1016/S0099-2399(06)81366-X.
Results Reference
background
PubMed Identifier
21496654
Citation
Simpson M, Drum M, Nusstein J, Reader A, Beck M. Effect of combination of preoperative ibuprofen/acetaminophen on the success of the inferior alveolar nerve block in patients with symptomatic irreversible pulpitis. J Endod. 2011 May;37(5):593-7. doi: 10.1016/j.joen.2011.02.015. Epub 2011 Mar 22.
Results Reference
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Preoperative Acetaminophen- Caffeine- Codeine Combination and Anaesthetic Success in Patients With Acute Pulpitis

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