Early Phase 1
N=114
Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment
Pain, Postoperative · Analgesia
Bottom Line
View on ClinicalTrials.gov: NCT02393339 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Mar 2021
Primary outcome: Primary: Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment — 20; 20; 7; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- paracetamol (Drug); placebo (Drug)
- Age
- Pediatric · 5+ yrs
- Sex
- All
- Sponsor
- Hadassah Medical Organization
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment |
20; 20; 7; 11; 10; 9 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02393339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.