Clinical trial NCT03423329: Effectiveness of Buccal Infiltration During Vital Pulpotomy After Administering Two Analgesic Premedications
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Local
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-02-06
Enrollment: 60
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. age group 7-9 years
2. Patients medically free.
3. Patients who can be categorized as cooperative or potentially cooperative according to Wright's classification for child behavior
4. Patients able to understand the use of pain scales;
5. Having at least one lower second primary molar with deep caries indicated for pulpotomy;
6. A vital coronal pulp on access opening of designated molar.

Exclusion Criteria:

1. Patients with allergic reactions, sensitivity, or contraindications to any tested drugs
2. Patients who had taken analgesics within 12 hours before administration of the study drugs
3. Patients having active pain, pulpitis or abscess related to the designated mandibular molar.
4. Children with special health care needs or any systemic problems
5. Presence of periapical or furcation radiolucency on radiographs in relation to designated molar
6. Presence of of any signs of internal or external resorption on radiographs in relation to designated molar

Primary outcomes:
measure: Pain/discomfort felt during vital pulpotomy of mandibular second primary molars
timeFrame: 75 minutes after drug administration
Secondary outcomes:
Other outcomes:
measure: Pain /discomfort in carious mandibular primary second molar
timeFrame: Just before drug administration
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry Ain Shams University
state: Other
Study officials:
affiliation: Ain Shams University
name: Reham Abou El Fadl, DDS
role: PRINCIPAL_INVESTIGATOR
References: