Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment

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

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Analgesia
• Intervention / Treatment: Drug: paracetamol; Drug: placebo

Detailed Description

This study will be a prospective, placebo-controlled, randomized, double-blind trial. Patients 5-12 years old, healthy, in need of dental treatment with local anesthesia of Lidocaine 2% with adrenalin 1:100,000 in the Hadassah School of Dental Medicine will take part in the study. The dental treatment will include one of the following procedures: restoration, pulpotomy, pulpectomy, stainless steel crown, extraction. Exclusion criteria: 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.

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.

Data collection: age, gender, type of treatment, type of LA (infiltration /block), time of taking the preoperative analgesic, type of preoperative analgesics ( 1 or 2), time at the end of the treatment and baseline apprehension. Baseline anxiety will be recorded prior to the procedure using Facial Image Scale.

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 The first two parts of the questionnaire (time 0, 1 h) will be answered in the clinic and the last part (time 2.5 h) by phone; the children will have the scale with the faces with them.

• Study Type: Interventional
• Enrollment (Actual): 114
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 91120
    • Hadassah Medical Organization

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy
• in need of dental treatment with local anesthesia

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: study group; Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment	Drug: paracetamol; Pre-operative administration of Paracetamol syrup; Other Names: acetaminophen
Placebo Comparator: controll group; Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.	Drug: placebo; Pre-operative administration of placebo syrup

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Actual): January 1, 2020
• Study Completion (Actual): January 31, 2020

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: March 18, 2015
• First Posted (Estimate): March 19, 2015

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: 0638-14-HMO-CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No