A Phase 4 interventional study of lidocaine and articaine in Anesthesia, Dental and Pain, Postoperative, sponsored by Boston University. Withdrawn at 1 site in United States. Open to participants aged 4 Years to 14 Years. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Boston University · Phase 4, Interventional, and Treatment
Among 116 studies testing lidocaine in Pain, Postoperative — 12 open to participants now, 15 under way, 5 of them phase 3. Lidocaine · Pain, Postoperative.
Among the 116 studies testing lidocaine in Pain, Postoperative, this one is the 113th largest by enrollment, is one of 7 that started in 2022, is one of 40 in phase 4, and was the 41st registered.
5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.
Browse Pain, Postoperative studies →12 of the 116 studies testing lidocaine in Pain, Postoperative are open now, in 10 countries. Each count lists the studies.
Lidocaine: first FDA approval 1948 (XYLOCAINE), first EMA approval 2013. What it is approved for, and how studies give it, is on its page →
Of the 679 Pain, Postoperative studies recruiting now, 241 (35%) set no upper age limit and 328 (48%) stop at 75 or younger; 74 take children under 18; 128 take healthy volunteers.
This study: 4 Years to 14 Years · all sexes · no healthy volunteers.
The full table on the hub →116 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 7 started in 2022.
Median enrollment 80 across the 116 interventional studies. Of the 79 that completed or were terminated, 11 (14%) have results posted.
2 of 116 have an industry lead sponsor. The 10 most frequent:
Boston University is the lead sponsor of 270 studies on the registry; 36 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.
Boston University has 4 studies filed under Pain, Postoperative — fewer than ten, so there is no comparison to draw.
5 of the studies testing lidocaine in Pain, Postoperative that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07871266Phase 3Assiut UniversityEffect of Nebulized Lignocaine on Emergence Agitation After Sevoflurane Anesthesia in Pediatric Patients Undergoing Tonsillectomy | 2027-11 |
| NCT07488832Ankara City Hospital BilkentIntravenous Lidocaine Infusion in Lumbar Fusion Surgery | 2027-01-01 |
| NCT07068243Duke UniversityREctus Sheath Trial | 2027-02 |
| NCT07012889Medical University of WarsawIntraoperative Continuous Lidocaine Infusion in Laparoscopic Liver Surgery | 2027-03-02 |
| NCT06884540CHU de Quebec-Universite LavalOptimizing Patient-centred Outcomes Using Opioid Minimization Strategies: The OPUS Anesthesia Pilot Trial | 2027-04 |
Among the 116 studies testing lidocaine in Pain, Postoperative, from their registry updates:
The purpose of this study is to compare the efficacy of two types of local anesthesia (articaine and lidocaine) for infiltration anesthesia during restorative dental procedures on lower teeth in pediatric patients. The patients will require similar dental operative procedures on both right and left sides of the mandible in order to qualify for this study. The study will require at least two dental appointments, where a randomized, cross-over study methodology will be utilized. All subjects will be treated by the same dentist. The comfort of the patient will be assessed at various points during the procedure using the Wong-Baker Faces Scale.
This study will compare articaine to lidocaine with overall quality of anesthesia. When administering lidocaine, the investigator will follow standard of care by administering a buccal infiltration injection followed by 2-3 interpapillary injections, one at each gingival papilla where the rubber dam clamp will be placed and possibly more if needed in areas where dental treatment will be provided. A single buccal infiltration injection of articaine will be administered, with the hypothesis that articaine is a stronger anesthestic and will deliver palatal anesthesia with a single injection, eliminating the interpapillary injections required for lidocaine to achieve adequate soft tissue anesthesia. The comfort of the patient during multiple steps of the dental treatment will be recorded. A randomized, cross-over methodology will be used. This study seeks to find whether adequate anesthesia in the mandible can be achieved with a single injection of articaine in the buccal aspect of the jaw instead of having to administer multiple injections of lidocaine, which can increase patient anxiety and discomfort. By decreasing the number of injections needed for children during dental treatment while providing adequate local anesthesia, dentists can provide more comfortable care to their pediatric patients.
Specific Aims/ Hypothesis
-Specific Aim 1: To compare articaine to lidocaine with achieving effective local anesthesia in the mandible and upper arch of pediatric dental patients.
Hypothesis: The solubility of articaine will provide more effective anesthetic delivery through the soft and hard tissue of the mandible following buccal infiltration, eliminating the need for multiple injections.
-Specific Aim 2: To identify which type of anesthetic provides the best patient experience by way of measuring patient comfort at various stages of the dental procedure.
Hypothesis: The patient will have an equally comfortable experience during the dental procedure when articaine or lidocaine is used.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
For the first dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed. For the second dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered.
Drug: lidocaine · Drug: articaine
For the first dental procedure a single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered. For the second dental procedure 2% lidocaine with 1:100,000 epinephrine will be administered with a buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed.
Drug: lidocaine · Drug: articaine
A buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed of 2% lidocaine with 1:100,000 epinephrine will be administered.
Also known as: local anesthetic
A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered
Also known as: local anesthetic
Pain during anesthesia injection using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Time frame: Anesthesia injection is usually about 10 min before the dental procedure starts.
Pain during rubber dam placement using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Time frame: Rubberdam placement is usually about 5 min before the dental procedure starts.
Pain during tooth preparation using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Time frame: Tooth preparation occurs during the dental procedure.
Pain during pulp opening using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Time frame: Pulp opening occurs during the dental procedure.
Pain during restoration placement using the Wong-Baker faces scale
Wong-Baker faces scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value with a range of 1 to 10. The higher the numeric value the more intense the pain.
Time frame: Restoration placement is at the end of the dental procedure, approximately 1 hour.
Additional injections of local anesthetic at the first visit
The number of extra injections to achieve anesthesia will be documented for each participant.
Time frame: At the completion of the first visit, approximately 1 hour.
Additional injections of local anesthetic at the second visit
The number of extra injections to achieve anesthesia will be documented for each participant.
Time frame: At the completion of the second visit, approximately 1 hour.
Plan to share: No
This study is withdrawn, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Lidocaine · Carticaine