Back to resultsEffect of Fentanyl on the Rate of Anesthesia
Primary Purpose
Painful Irreversible Pulpitis
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lidocaine with Epinephrine+ Normal saline
Lidocaine with Epinephrine + fentanyl
Sponsored by
About this trial
This is an interventional prevention trial for Painful Irreversible Pulpitis focused on measuring Irreversible Pulpitis, Infiltration injection, Fentanyl, Lidocaine
Eligibility Criteria
Inclusion Criteria:
- Patients were aged between 18 and 65 years with no systemic diseases categorized in the Class I ASA;
- Individuals requiring urgent root canal treatment of maxillary first or second molars;
- Hot painful teeth with irreversible pulpitis (moderate to severe spontaneous pain), with a positive response to thermal vitality tests (a long painful response to a cold test) and no clinical or radiographic signs or symptoms of acute or chronic apical periodontitis; and
- No history of taking analgesics in the previous 12 h.
Exclusion Criteria:
- Systemic conditions;
- Allergic reactions to opioids, benzodiazepines, barbiturates;
- Pregnancy and lactation; Contraindication of the use of epinephrine (such as unstable angina);
- Nonvital pulp after access cavity preparation
Sites / Locations
- Islamic Azad University
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Lidocaine with Epinephrine+ Normal saline
Lidocaine with Epinephrine + fentanyl
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline in depth of anesthesia
The measuring method of the pain is Electric pulp tester
Secondary Outcome Measures
change from baseline in intensity of the pain
using visual analog scale(VAS)
Full Information
NCT ID
NCT01794533
First Posted
January 30, 2013
Last Updated
February 16, 2013
Sponsor
Islamic Azad University, Tehran
1. Study Identification
Unique Protocol Identification Number
NCT01794533
Brief Title
Effect of Fentanyl on the Rate of Anesthesia
Official Title
Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Islamic Azad University, Tehran
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Achievement of a deep and long-durated anesthesia is vital before most endodontic procedures; therefore, the investigators conducted this study to compare the local infiltration effect of epinephrine-containing lidocaine with/ without fentanyl on depth and duration of anesthesia in maxillary molars with painful irreversible pulpitis.
Detailed Description
This study was planned with a randomized double-blind, parallel design clinical trial on 64 healthy patients after taking into account some inclusion and exclusion criteria. The control group were received the mixture of normal saline and 2% lidocaine with 1:200,000 epinephrine and the experimental group were received the mixture of fentanyl and 2% lidocaine with 1:200,000 epinephrine. The depth and duration of pulpal anesthesia were evaluated with an electric pulp testing in 5-minute intervals during a period of 60 minutes and the pain intensity recorded in five times, before injection, after injection, during access cavity preparation, pulpotomy and pulpectomy using visual analog scale(VAS). All data were analyzed and compared using chi-squared and Mann-Whitney tests.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Painful Irreversible Pulpitis
Keywords
Irreversible Pulpitis, Infiltration injection, Fentanyl, Lidocaine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine with Epinephrine+ Normal saline
Arm Type
Placebo Comparator
Arm Title
Lidocaine with Epinephrine + fentanyl
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine with Epinephrine+ Normal saline
Intervention Description
local infiltration of 1.8 mL of 2% lidocaine containing 1:200,000 epinephrine along with 0.8 mL of 0.9% sterile normal saline solution
Intervention Type
Drug
Intervention Name(s)
Lidocaine with Epinephrine + fentanyl
Other Intervention Name(s)
Sublimaze,fentanil
Intervention Description
local infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg)
Primary Outcome Measure Information:
Title
Change from Baseline in depth of anesthesia
Description
The measuring method of the pain is Electric pulp tester
Time Frame
Change from Baseline up to 17 minutes
Secondary Outcome Measure Information:
Title
change from baseline in intensity of the pain
Description
using visual analog scale(VAS)
Time Frame
Change from Baseline up to 60 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients were aged between 18 and 65 years with no systemic diseases categorized in the Class I ASA;
Individuals requiring urgent root canal treatment of maxillary first or second molars;
Hot painful teeth with irreversible pulpitis (moderate to severe spontaneous pain), with a positive response to thermal vitality tests (a long painful response to a cold test) and no clinical or radiographic signs or symptoms of acute or chronic apical periodontitis; and
No history of taking analgesics in the previous 12 h.
Exclusion Criteria:
Systemic conditions;
Allergic reactions to opioids, benzodiazepines, barbiturates;
Pregnancy and lactation; Contraindication of the use of epinephrine (such as unstable angina);
Nonvital pulp after access cavity preparation
Facility Information:
Facility Name
Islamic Azad University
City
Tehran
ZIP/Postal Code
19585-175
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Effect of Fentanyl on the Rate of Anesthesia
We'll reach out to this number within 24 hrs