Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment

Early Phase 1

Completed

Conditions: Analgesia
Pain, Postoperative

Interventions: Drug: placebo
Drug: paracetamol

Registration Number: NCT02393339

Lead Sponsor: Hadassah Medical Organization

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 114

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controll group	placebo	Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.
study group	paracetamol	Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment

Primary Outcome Measures

Name	Time	Method
Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment	2.5 hours after taking the pre-operative analgesic.	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.

Secondary Outcome Measures