CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 114 enrolled
Drug / intervention
paracetamol +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02393339
NCT02393339Early Ph 1Completed

Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment

Hadassah Medical Organization·interventional·Posted Mar 19, 2015·Updated Mar 3, 2021

In Brief

A Early Phase 1 clinical trial evaluating paracetamol and placebo for Pain, Postoperative and Analgesia. Completed, enrolled 114 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesIsrael
Collaborators--

Timeline

Early Ph 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 19, 2015
Enrollment StartFeb 1, 2017
Primary CompletionJan 1, 2020
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.3 years ago

Interventions

paracetamoldrug

Pre-operative administration of Paracetamol syrup

placebodrug

Pre-operative administration of placebo syrup