ORAL HEALTH EVIDENCE-BASED PRACTICE PROGRAM
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Title Oraverse (phentolamine mesylate) is Safe and Effective for Use in Pediatric Dental Patients
Clinical Question In pediatric dental patients, does phentolamine mesylate act as a safe and effective local anesthetic reversal agent?
Clinical Bottom Line Phentolamine mesylate can be considered safe and effective for use in pediatric dental patients. It successfully reverses soft tissue anesthesia, therefore reducing the risk of post-operative trauma in children.
Best Evidence (you may view more info by clicking on the PubMed ID link)
PubMed ID Author / Year Patient Group Study type
(level of evidence)
#1) 18682624Tavares/2008152 pediatric dental patients, ages 4 through 11Randomized controlled trial, Double-blind, Phase II clinical trial
Key resultsThe patients were randomized into two groups, with the first group receiving a phentolamine mesylate injection and the second group receiving a control (“sham”) injection. Patients were observed for potential adverse events and residual tissue anesthesia. This study found no significant difference in the risk of adverse events between the experimental and the control group. Post-operative recovery time for the return of normal lip sensation was shorter in the experimental group (median 60 minutes) than the control group (median 135 minutes). This is equivalent to a 55.6% reduction in recovery time for the phentolamine mesylate group compared to the control group.
#2) 24991590Nourbakhsh/201254 pediatric dental patients, ages 4 through 11Randomized controlled trial, Double-blind, Clinical trial
Key resultsThe patients were randomized into two groups. The first group received a phentolamine mesylate injection in the first appointment, and a control (“sham”) injection in the second appointment. The second group received the same treatment as above, except the order of the appointments was reversed. Patients were observed for potential adverse events and residual tissue anesthesia. Post-operative recovery time for the return of normal lip sensation was shorter at the phentolamine mesylate appointment (Group 1: 29.47 min; Group 2: 33.12 min) than the control appointment (Group 1: 135.2 min; Group 2: 106.04 min). The risk of post-operative soft tissue trauma was higher after the control appointment (19%) than after the phentolamine mesylate appointment (2%). Both of these findings were statistically significant.
#3) 26409985Prados-Frutos/20156 Randomized controlled trials includedSystematic Review; Meta-Analysis
Key resultsThe articles by Tavares et al and Nourbakhsh et al were described as having an unclear risk of bias due to their lack of information. Overall, none of the randomized controlled trials were considered to have a low risk of bias. Limited evidence demonstrated that phentolamine mesylate successfully reduces the duration of residual anesthesia. Adverse effects are rare. In order to accurately quantify the recovery time provided by phentolamine mesylate, additional high quality randomized controlled trials are required.
Evidence Search ((phentolamine) AND reversal) AND pediatric
Comments on
The Evidence
There have been relatively few studies conducted on the efficacy and safety of phentolamine mesylate in children. Although the systematic review did not exclusively consider pediatric patients, it was still included due to its valuable insight into the studies performed by Tavares et al and Nourbasksh et al. The study conducted by Tavares et al had a sufficiently large subject group. However, additional studies with larger subject groups are required to accurately quantify the reduction in anesthesia duration and to identify rare potential adverse events. The study conducted by Nourbakhsh et al was interesting in that each child acted as his/her own control. Future randomized controlled trials could be designed in a similar manner in order to reduce the risk of bias and confounding factors. In both studies, the reviewers were blinded to the treatment delivered. However, the systematic review noted that the overall risk of bias for each trial was still unclear due to the omission of important data (i.e., randomization process). Notably, the study conducted by Tavares et al was funded by Novalar Pharmaceuticals, and seven out of its nine authors reported potential conflicts of interest. Unfortunately, this study therefore has a higher potential risk of bias. Finally, note that these studies were conducted in healthy patients. Further studies are needed to determine the safety of phentolamine mesylate in medically compromised children. Even though, the above studies demonstrate that the use of phentolamine mesylate is both safe and effective in children aged 4 through 11, the manufacturer does not recommend its use on patients under 6 years of age. In healthy children weighing 15 kg-30kg, a dose of 0.2mg phentolamine mesylate may be considered safe and effective. In healthy children weighing greater than 30kg, a dose of 0.4mg phentolamine mesylate may be considered safe and effective.
Applicability This study is applicable to pediatric and general dentists treating healthy children who present with a higher risk of post-operative soft tissue trauma.
Specialty/Discipline (General Dentistry) (Pediatric Dentistry) (Restorative Dentistry)
Keywords phentolamine, pediatric patients, Oraverse, local anesthesia reversal
ID# 2930
Date of submission: 10/15/2015spacer
E-mail maye@livemail.uthscsa.edu
Author Elizabeth May, DDS
Co-author(s)
Co-author(s) e-mail
Faculty mentor/Co-author Maria Mendez Cervantes, DDS
Faculty mentor/Co-author e-mail CervantesMen@uthscsa.edu
Basic Science Rationale
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Comments on the CAT
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