Effect of Fentanyl on the Rate of Anesthesia
Information source: Islamic Azad University, Tehran
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Painful Irreversible Pulpitis
Intervention: Lidocaine with Epinephrine+ Normal saline (Drug); Lidocaine with Epinephrine + fentanyl (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Islamic Azad University, Tehran
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.
Clinical Details
Official title: Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Change from Baseline in depth of anesthesia
Secondary outcome: change from baseline in intensity of the pain
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 56 Years.
Gender(s): Both.
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
Locations and Contacts
Islamic Azad University, Tehran 19585-175, Iran, Islamic Republic of
Additional Information
Starting date: October 2012
Last updated: February 16, 2013
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