Pre-operative Analgesics for Postoperative Pain Relief After Dental Treatment
Condition: Pain, Postoperative; Analgesia
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Early Phase 1

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.
    

Intervention name(s): paracetamol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pre-operative administration of Paracetamol syrup; Pre-operative administration of placebo syrup
Other intervention name(s): acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment