NCT03423329

Effectiveness of Buccal Infiltration During Vital Pulpotomy After Administering Two Analgesic Premedications

Effect of Preoperative Oral Administration of Ibuprofen and Acetaminophen on the Anesthetic Efficacy of Buccal Infiltration During Vital Pulpotomy of Mandibular Primary Molars: A Prospective, Double-blinded, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 7 Years – 9 Years
• Healthy volunteers: Accepted

Summary

This Randomized study was designed to assess and compare the effect of two analgesic premedications (Ibuprofen BP 100 mg/5 ml and Paracetamol 200 mg/5ml.) on the anesthetic efficacy of buccal infiltration in vital pulpotomy of primary mandibular molars in children . A multivitamin with the same color as the twp tested medications will be administered to children in the control group. Parents of eligible children will be informed about the nature of the procedure, the purpose of the study, any possible discomfort or risks and a signed informed consent will be obtained from them prior to enrollment.

Detailed description

A total of 60 healthy children will be recruited from the outpatient clinic of the Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University. Inclusion Criteria include: age group 7-9 years Without systemic or mental disorders. Who could be categorized as cooperative according to Wright's classification for child behavior Ability of child to understand the use of pain scales; Having at least one lower second primary molar with deep caries indicated for pulpotomy; Absence of any periapical or furcation radiolucency on radiographs, Absence of any signs of internal or external resorption on radiographs, A vital coronal pulp on access opening. . Patients who had taken analgesics within 12 hours before administration of the study drugs or those having active pain, pulpitis or abscess related to the designated mandibular molar will not be included. To ensure randomization and allocation concealment, children will be randomly assigned to the three groups using computer-generated numbers. One operator will do pulpotomy for all participants and to ensure blinding, another author ( will give the premedication to children.Pain during pulpotomy will be assessed using Wong Baker FACES pain assessment tool.

Conditions

• Anesthesia, Local

Interventions

Type	Name	Description
DRUG	Brufen	Brufen Syrup
DRUG	Cital	Cital Cyrup
DRUG	Placebo for Brufen	Sansovit Syrup

Timeline

• Start date: 2018-01-20
• Primary completion: 2018-04-25
• Completion: 2018-04-25
• First posted: 2018-02-06
• Last updated: 2018-11-15

Locations

1 site across 1 country: Egypt