Phentolamine mesylate effect on duration of soft tissue local anesthesia and incidence of soft tissue trauma after local anesthesia

Phentolamine mesylate effect on duration of soft tissue local anesthesia and incidence of soft tissue trauma after mandibular injection in children in 4-6 years of age

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT201102285934N1

Enrollment

Registered

2012-05-17

Start date

2011-04-09

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effectiveness ofphentolamine mesylate on the adverse effect of local anesthesia. Local anaesthetics

Interventions

Intervention 1: Injection of phentolamine mesylate for pediatrics who weighted 15 kg or more and less than 30 kg receive one-half cartridge of anesthetics.Those weighing 30 kg or more received wole ca

Treatment - Drugs

Placebo

Injection of phentolamine mesylate for pediatrics who weighted 15 kg or more and less than 30 kg receive one-half cartridge of anesthetics.Those weighing 30 kg or more received wole cartridge- Phentol

In control group, we apply the sham injection(needle does note penetrate the tissue) in the same side that local anesthesia has been injected.

Eligibility

Sex/Gender

All

Age

4 Years to 6 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: systematically healthy children who require routine dental treatment without alergies or intolerance to anesthetics, epinephrine, sulfites patient that requires bilateral dental procedure except extraction(2%lidocaine with 1/80000 epinephrine) andhaving weight equal or greater than 15kg. Exclusion criteria: patient requires more than 1 cartrdge of lidocain with 1/80000 epinephrine or another local anesthetic, sedation, lesser than 15kg and younger than 4 years of age.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The effectiveness of phentolamine mesylate on the reduction of reversal time of numbness of soft tissue. Timepoint: 15 minutes. Method of measurement: A soft tapping by index finger to the trained children.;Trauma to soft tissue. Timepoint: Every 30 minutes. Method of measurement: Inspection.	—

Secondary

Measure	Time frame
The probability of change in the blood pressure. Timepoint: Every 30 minutes. Method of measurement: Digital sphygmomanometer.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. M ahdi Babaei

Dentistry college,Isfahan University of Medical Sciences

babaei@edc.mui.ac.ir+98 31 1788 3314

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026