Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment

NCT02393339 | Completed Early Phase 1 Results

• 1 other identifier: 0638-14-HMO-CTIL
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare the efficacy of the pre-operative administration of Paracetamol and placebo in reducing postoperative pain after routine dental treatment in children. This study will be a prospective, placebo-controlled, randomized, double-blind trial. Patients in need of dental treatment with local anesthesia will take part in the study. Study group will receive syrup paracetamol 15 min before the dental treatment. Control group will receive placebo syrup, similar in color and viscosity, 15 min before dental treatment. the patient, the treating dentist, and the interviewer will be blind to the medication. Main outcome measure: one of the main investigators will interview the patient at three time points: immediately at the end of the treatment, one hour after taking the pre-operative analgesic and by phone 2.5 hours after taking the pre-operative analgesic. The patient and his parents will be asked if the child is crying (yes/no), complaining about pain (yes/no), needed a different kind of analgesics after the treatment (yes/no). In addition, each child will describe his ⁄ her feelings regarding postoperative pain, using the Wong-Baker Facial Rating Pain Scale

Conditions

Pain, Postoperative; Analgesia

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment

  This scale measures the unpleasantness or effective dimension of a child's pain experience. The child is shown a set of six cartoon faces with varying facial expressions from smile\\laughter to tears. Each face has a numerical value, from 0 (smiling face) to 5 (tears). The child selects the facial expression that best represents his \\her experience of discomfort.

  2.5 hours after taking the pre-operative analgesic.

Study Arms (2)

study group

ACTIVE COMPARATOR

Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment

Drug: paracetamol

controll group

PLACEBO COMPARATOR

Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.

Drug: placebo

Interventions

paracetamol DRUG

Pre-operative administration of Paracetamol syrup

Also known as: acetaminophen

study group

placebo DRUG

Pre-operative administration of placebo syrup

controll group

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• healthy
• in need of dental treatment with local anesthesia

You may not qualify if:

• preoperative pain,
• patients taking analgesics within 5 h prior to the dental treatment
• allergic reaction or adverse effect to paracetamol
• not available (by phone) at least 2 hours after treatment
• patient refuse to drink the syrup
• dental treatment without local anesthesia

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Acetaminophen

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Avia Fux-Noy
• Organization: Hadassah School of Dental Medicine, P.O.Box 12272

fuxavia@gmail.com

+972507410935

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pediatric dentist

Study Record Dates

• First Submitted: March 9, 2015
• First Posted: March 19, 2015
• Study Start: February 1, 2017
• Primary Completion: January 1, 2020
• Study Completion: January 31, 2020
• Last Updated: March 3, 2021
• Results First Posted: March 3, 2021

Record last verified: 2021-03

Locations

IL (1)