Painful Irreversible PulpitisPhase 2NCT01794533
Effect of Fentanyl on the Rate of Anesthesia
A Phase 2 study testing Lidocaine with Epinephrine+ Normal saline and Lidocaine with Epinephrine + fentanyl in people with Painful Irreversible Pulpitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 56 yearsHealthy volunteers can take part
- Conditions the study is for
- Painful Irreversible Pulpitis
- What is being tested?
- Lidocaine with Epinephrine+ Normal saline and Lidocaine with Epinephrine + fentanyl
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteIran
- Study dates
- Oct 2012to Jan 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 56 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis
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.
Read the 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.
- Conditions
- Painful Irreversible Pulpitis
- Being tested
- Lidocaine with Epinephrine+ Normal saline, Lidocaine with Epinephrine + fentanyl
- Keywords
- Irreversible Pulpitis, Infiltration injection, Fentanyl, Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine with Epinephrine+ Normal salineDrug
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
Lidocaine with Epinephrine + fentanylDrug
Also called Sublimaze,fentanil
local infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg)
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine with Epinephrine+ Normal saline | Placebo comparator | Not described Receives: Drug: Lidocaine with Epinephrine+ Normal saline; Drug: Lidocaine with Epinephrine + fentanyl |
| Lidocaine with Epinephrine + fentanyl | Active comparator | Not described Receives: Drug: Lidocaine with Epinephrine+ Normal saline; Drug: Lidocaine with Epinephrine + fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in depth of anesthesia
The measuring method of the pain is Electric pulp tester
Measured: Change from Baseline up to 17 minutes
Secondary outcomes (1)
change from baseline in intensity of the pain
using visual analog scale(VAS)
Measured: Change from Baseline up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Irreversible PulpitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Islamic Azad University, Sanandaj
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatemeh khodaei, Islamic Azad University, Sanandaj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01794533
- Sponsor's protocol ID
- 18050
- Status last verified
- Feb 2013
- First submitted
- 30 Jan 2013
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of a Combination of Fentanyl and Lidocaine for Maxillary Infiltration in Teeth With Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT01794533
- Acronym / sponsor ID
- 18050
- Conditions
- Painful Irreversible Pulpitis
- Keywords
- Irreversible Pulpitis, Infiltration injection, Fentanyl, Lidocaine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Islamic Azad University, SanandajUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine with Epinephrine+ Normal saline | Placebo comparator | Drug: Lidocaine with Epinephrine+ Normal saline, Drug: Lidocaine with Epinephrine + fentanyl |
| Lidocaine with Epinephrine + fentanyl | Active comparator | Drug: Lidocaine with Epinephrine+ Normal saline, Drug: Lidocaine with Epinephrine + fentanyl |
Who may qualify
- Ages
- 18 to 56 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine with Epinephrine+ Normal salinelocal 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 | Drug | Lidocaine with Epinephrine + fentanyl, Lidocaine with Epinephrine+ Normal saline |
| Lidocaine with Epinephrine + fentanylAlso: Sublimaze,fentanillocal infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg) | Drug | Lidocaine with Epinephrine + fentanyl, Lidocaine with Epinephrine+ Normal saline |
Primary outcome
Change from Baseline in depth of anesthesia
Time frame: Change from Baseline up to 17 minutes
The measuring method of the pain is Electric pulp tester
1 secondary outcome
change from baseline in intensity of the pain
Time frame: Change from Baseline up to 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lidocaine with Epinephrine+ Normal saline and Lidocaine with Epinephrine + fentanyl in people with Painful Irreversible Pulpitis, run by Islamic Azad University, Sanandaj at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in depth of anesthesia (time frame: Change from Baseline up to 17 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.