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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: Drug: Brufen; Drug: Placebo for Brufen; Drug: Cital

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Other
    • Cairo, Other, Egypt, 11341
      • Faculty of dentistry Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 9 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Intervention:Drug: Brufen & Placebo Brufen syrup 10 ml, once, 1 hour before local anesthesia	Drug: Brufen; Brufen Syrup; Other Names: Advil; Nurfen; Drug: Placebo for Brufen; Sansovit Syrup; Other Names: Placebo for Cital
Experimental: Group B; Intervention: Drug: Cital and Placebo Cital Syrup 10 ml, once 1 hour before Local anesthesia	Drug: Placebo for Brufen; Sansovit Syrup; Other Names: Placebo for Cital; Drug: Cital; Cital Cyrup; Other Names: Paramol
Placebo Comparator: Group C; Intervention: Drug: Placebo Other names: (Placebo for Brufen) (Placebo for Cital) Sansovit Iron Multivitamin syrup, an orange-coloured, orange-flavoured	Drug: Brufen; Brufen Syrup; Other Names: Advil; Nurfen; Drug: Placebo for Brufen; Sansovit Syrup; Other Names: Placebo for Cital; Drug: Cital; Cital Cyrup; Other Names: Paramol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain/discomfort felt during vital pulpotomy of mandibular second primary molars	Using Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt during coronal access	75 minutes after drug administration

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain /discomfort in carious mandibular primary second molar	Using Wong Baker FACES pain assessment tool Children will be asked to rate any pain felt in designated molar before treatment	Just before drug administration

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Reham Abou El Fadl, DDS, Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2018
• Primary Completion (Actual): April 25, 2018
• Study Completion (Actual): April 25, 2018

Study Registration Dates

• First Submitted: December 28, 2017
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 6, 2018

Study Record Updates

• Last Update Posted (Actual): November 15, 2018
• Last Update Submitted That Met QC Criteria: November 13, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ibuprofen
• Other Study ID Numbers: FDASU-REC R 071607

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Within one month after study completion
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No