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

Ain Shams University

Status: Completed

Conditions: Anesthesia, Local

Treatments: Drug: Placebo for Brufen; Drug: Brufen; Drug: Cital

Study type: Interventional

Funder types: Other

Identifiers

NCT03423329

FDASU-REC R 071607

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 7 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups, including a placebo group

Group A

Experimental group

Description:

Intervention:Drug: Brufen \& Placebo Brufen syrup 10 ml, once, 1 hour before local anesthesia

Treatment:

Drug: Brufen

Drug: Placebo for Brufen

Group B

Experimental group

Description:

Intervention: Drug: Cital and Placebo Cital Syrup 10 ml, once 1 hour before Local anesthesia

Treatment:

Drug: Cital

Drug: Placebo for Brufen

Group C

Placebo Comparator group

Description:

Intervention: Drug: Placebo Other names: (Placebo for Brufen) (Placebo for Cital) Sansovit Iron Multivitamin syrup, an orange-coloured, orange-flavoured

Treatment:

Drug: Cital

Drug: Brufen

Drug: Placebo for Brufen