AnesthesiaNCT03261115
Effects of Benzocaine 20% Topical Anesthetic and no Topical Agent on Pain Perception During Intra-oral Injections
A study testing No topical anesthesia in people with Anesthesia, run by Nurain Rehman at 1 site in Pakistan.
Trial summary
The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia against the use of no topical agent during buccal infiltration in maxillary anterior teeth. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia
- What is being tested?
- No topical anesthesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Aug 2017to 20 Sep 2017
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Above the age of 18
- Males and females both
- Participants requiring extraction of maxillary anterior teeth
- Intact or minimally restored anterior teeth
- Patients with American Society of Anesthesiologists physical status of 1 or 2
Who cannot join
- Participants with physical American Society of Anesthesiologists physical status of 3 or 4
- Showing signs of inflammation in the area to be injected
- Having known allergy to any of the agents used in the study
- Used anti- anxiety drugs or sedatives in the past two weeks
- Have taken analgesics on the day of data collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Topical Benzocaine in Anterior Maxilla: A Randomised Controlled Trial
The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia against the use of no topical agent during buccal infiltration in maxillary anterior teeth. The rationale behind this comparison is to evaluate the practical, clinical outcome of not using any topical agent if in fact topical anesthesia does not reduce pain as reported by various studies and if consequently its usage was to be discontinued.
Read the detailed description
The clinical implication of topical anesthesia and placebo being the same is to not use either of them prior to LA administration in dentistry. This clinical approach has rarely been studied and this study aims to compare the effects of the use of topical anesthesia against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.
- Conditions
- Anesthesia
- Being tested
- No topical anesthesia
- Keywords
- Pain, Benzocaine, Clinical trial
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No topical anesthesiaProcedure or surgery
Lack of use of topical anesthesia application prior to infiltration injection intra-orally
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Topical Anesthesia |
| Study group | Experimental | No topical anesthesia Receives: Procedure: No topical anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score on needle penetration
Pain score measured by numeric pain rating scale
Measured: Immediately
Pain score on local anesthesia deposition
Pain score measured by numeric pain rating scale
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start16 Aug 2017
- Primary completion16 Sep 2017
- Study completion20 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nurain Rehman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurain Rehman, CMH Lahore Medical College and Institute of Dentistry
- Investigators
- Nurain Rehman, Principal investigator, CMH Lahore Medical College and Institute of DentistrySamir Qazi, FFDRCSI, Study director, CMH Lahore Medical College and Institute of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261115
- Sponsor's protocol ID
- NR3517
- Status last verified
- Oct 2017
- First submitted
- 18 Aug 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rehman N, Qazi SR. Efficacy of Topical Benzocaine in Maxilla: A Randomized Controlled Trial. Anesth Prog. 2019 Spring;66(1):24-29. doi: 10.2344/anpr-66-01-01.
PubMed 30883233
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Topical Benzocaine in Anterior Maxilla: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03261115
- Acronym / sponsor ID
- NR3517
- Conditions
- Anesthesia
- Keywords
- Pain, Benzocaine, Clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Nurain RehmanUniversity, hospital or other
- Study start
- 16 Aug 2017 (actual)
- Primary completion
- 16 Sep 2017 (actual)
- Study completion
- 20 Sep 2017 (actual)
- First posted
- 24 Aug 2017 (actual)
- 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.
The aim of this randomized controlled trial. is to test the efficacy of topical anesthesia against the use of no topical agent during buccal infiltration in maxillary anterior teeth. The rationale behind this comparison is to evaluate the practical, clinical outcome of not using any topical agent if in fact topical anesthesia does not reduce pain as reported by various studies and if consequently its usage was to be discontinued.
Detailed description
The clinical implication of topical anesthesia and placebo being the same is to not use either of them prior to LA administration in dentistry. This clinical approach has rarely been studied and this study aims to compare the effects of the use of topical anesthesia against the use of no topical agent prior to buccal infiltration in maxillary anterior teeth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Topical Anesthesia |
| Study group | Experimental | Procedure: No topical anesthesiaNo topical anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Above the age of 18
- Males and females both
- Participants requiring extraction of maxillary anterior teeth
- Intact or minimally restored anterior teeth
- Patients with American Society of Anesthesiologists physical status of 1 or 2
Key exclusion criteria (5 listed)
- Participants with physical American Society of Anesthesiologists physical status of 3 or 4
- Showing signs of inflammation in the area to be injected
- Having known allergy to any of the agents used in the study
- Used anti- anxiety drugs or sedatives in the past two weeks
- Have taken analgesics on the day of data collection
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 |
|---|---|---|
| No topical anesthesiaLack of use of topical anesthesia application prior to infiltration injection intra-orally | Procedure or surgery | Study group |
Primary outcome
Pain score on needle penetration
Time frame: Immediately
Pain score measured by numeric pain rating scale
Pain score on local anesthesia deposition
Time frame: Immediately
Pain score measured by numeric pain rating scale
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 9 Oct 2017.
- Derived from this study: PubMed 30883233Rehman N, Qazi SR. Efficacy of Topical Benzocaine in Maxilla: A Randomized Controlled Trial. Anesth Prog. 2019 Spring;66(1):24-29. doi: 10.2344/anpr-66-01-01.
- Individual participant dataSharing planned: No
Related trials for Anesthesia
Not yet recruitingObservational study
"Comparison of Oxygen Reserve Index (ORI), End-Tidal Oxygen, and Time-Based Preoxygenation Targets With Arterial Blood Gas During Preoxygenation
Preoxygenation Adequacy Assessed by Oxygen Reserve Index, End-tidal Oxygen and Arterial Blood Gas
RecruitingObservational study
Comparison of Hemodynamic Responses During Anesthesia Induction Using Eleveld and Schnider
Spinal (Fusion) Surgery, Total Intravenous Anesthesia
Not yet recruiting
A Randomized Controlled SaCo-VLM Trial
General Anaesthesia Using Supraglotic Airway
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 4
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
Comparison of Hemodynamics and Respiratory Function Between Ciprofol and Propofol in Elderly Patients Undergoing Non-intubated General Anesthesia
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.
Nurain Rehman principal investigator
CMH Lahore Medical College and Institute of Dentistry
Samir Qazi, FFDRCSI study director
CMH Lahore Medical College and Institute of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No topical anesthesia in people with Anesthesia, run by Nurain Rehman at 1 site in Pakistan.
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 5 inclusion and 5 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 9 Oct 2017. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Pain score on needle penetration (time frame: Immediately). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261115, which also lists 1 linked publication.
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 9 Oct 2017.