Analgesia, Pain, Postoperative
Conditions
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.
Interventions
DRUGparacetamol
Pre-operative administration of Paracetamol syrup
DRUGplacebo
Pre-operative administration of placebo syrup
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group Study group will receive syrup paracetamol (15 mg/kg) 15 min before the dental treatment
paracetamol: Pre-operative administration of Paracetamol syrup | 51 |
| Controll Group Control group will receive placebo syrup, designed to mimic paracetamol syrup, similar in color and viscosity, 15 min before dental treatment.
placebo: Pre-operative administration of placebo syrup | 51 |
| Total | 102 |
Baseline characteristics
| Characteristic | Controll Group | Total | Study Group |
|---|---|---|---|
| Age, Continuous | 7.08 years STANDARD_DEVIATION 1.89 | 7 years STANDARD_DEVIATION 1.72 | 6.98 years STANDARD_DEVIATION 1.53 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Israel | 51 participants | 102 participants | 51 participants |
| Sex: Female, Male Female | 24 Participants | 44 Participants | 20 Participants |
| Sex: Female, Male Male | 27 Participants | 58 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 |
| other Total, other adverse events | 0 / 51 | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 | 0 / 51 |
Outcome results
Primary
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.
Time frame: 2.5 hours after taking the pre-operative analgesic.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 4 | 0 Participants |
| Study Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 0 | 20 Participants |
| Study Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 1 | 7 Participants |
| Study Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 2 | 10 Participants |
| Study Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 3 | 5 Participants |
| Study Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 5 | 9 Participants |
| Controll Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 3 | 3 Participants |
| Controll Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 4 | 2 Participants |
| Controll Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 2 | 9 Participants |
| Controll Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 0 | 20 Participants |
| Controll Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 5 | 6 Participants |
| Controll Group | Postoperative Pain, as Measured by Wong-Baker Facial Rating Pain Scale ,After Routine Dental Treatment | Wang-Baker Scale 1 | 11 Participants |