The effect of premedication With Ibuprofen on intra-operative pain during pulp therapy in primary molars

Evaluation of the effect of premedication with Ibuprofen on the pain during pulp therapy in mandibular primary molars

Double blinded, controlled, randomized clinical trial, with blinded outcome analysis

In this study, patient, physician (who recorded the pain score) and statistician was blinded to the groups. A total of 60 patients with 6 to 10 years of old , who visited the clinic of pediatric dentistry in Qazvin Dental School, were randomly divided into two groups. 45 minutes prior to treatment, the child was asked to explain the severity of his/her pain according to the Face Pain Scale-Revised(FPS-R) and placebo or ibuprofen was administered based on the patient's weight (10 mg / kg); then, inferior alveolar nerve block was performed. The access cavity was prepared by dentist and the pain during pulp exposure time was recorded according to FPS-R. Pulp therapy was then accomplished.

inclusion criteria: Children aged 6 to 10 years old; without the history of allergy to the NSAIDs group of drugs; with systemic and mental health and Frankle cooperation level of 3 or 4 ;who had a mandibular primary molar with spontaneous pain that could be restored. Exclusion criteria: Children who had taken any analgesics in previous 24 hours and the teeth requiring other treatments than pulp therapy.

Intervention group: Ibuprofen Prescribing 120mg/5ml ibuprofen suspension (Emad Darman Pars Co.) according to patient's weight (10 mg/kg), 45 minutes prior to administration of inferior alveolar nerve block. Control group: Placebo(fruit juice) Prescribing placebo according to patient's weight (10 mg/kg), 45 minutes prior to administration of inferior alveolar nerve block.

Pain during pulp therapy

Random allocation was done with "Random Allocation Software Version 2.0". This software has been produced to support the first type of randomization. The sample size (60) and number of groups (2 groups) were inserted to the software. The output data was a random sequence of numbers 1 to 60, allocating in two groups of A and B. The sequence was offered to the pharmacist. Bottles including drug (group A) and placebo (group B) was numbered according to the random sequence.

A pharmacist prepared placebo and ibuprofen with the same flavor and only the pharmacist was aware of the coded bottles' content. After the completion of treatment, data was sent to the statistician with the codes of 1 and 2. Therefore, patient, physician(who recorded the pain score) and statistician were blinded to the groups.