Effect of Preoperative Administration of Ibuprofen in Children Undergoing Extraction for Reducing Postoperative Pain: A Double-blind Randomized Controlled Clinical Trial

Aims The aim of this study was to compare the post-operative pain and anxiety experience of pediatric tooth extraction patients who receive a preoperative NSAID with those who receive a placebo in order to evaluate the impact of preoperative NSAID administration on post-surgical pain and anxiety.

Design This was a randomized, double-blind, placebo-controlled clinical trial. Setting This study was conducted at Princess Nourah Bint Abdulrahman University's (PNU's) dental clinic in Riyadh, Saudi Arabia.

Materials and Methods Participants Pediatric patients were referred to the study by clinicians at the PNU clinic. Inclusion criteria included: child must have been age five through 13; child must be undergoing a simple extraction under local anesthesia of one or more symptomatic primary molars including teeth with pathology such as abscess, cyst, and internal resorption; parent must provide consent and the child provide assent; child must not have any systematic disease, child must not be taking any medication that interacts with ibuprofen (the NSAID used in this study), and child must be cooperative. Children were excluded for known allergy or having ever had an allergic reaction to ibuprofen; taking antibiotics or other medications; having special needs due to a physical or mental disability; having been given an analgesic prior to appointment by guardian; or being treated for an emergency medical condition (e.g., cellulitis). This study was reviewed and approved by the PNU Research Ethics Board (REB).

Records of potential participants were reviewed prior to inviting them into study participation so that they were already screened for inclusion and exclusion criteria and they were known to qualify. This was a clinical study, and recruitment was limited to participants who qualified, although a total sample size of 60 was thought to be possible and so was targeted.

Randomization, Blinding, and Baseline Data Collection To facilitate double-blinding, a professional research coordinator (RC) was hired to develop blinded materials. A list of identification numbers was created and each number was randomly assigned to either Group A (receive ibuprofen prior to extraction) or Group B (receive placebo prior to extraction, as a control). Only the RC knew the assignment of the numbers to groups. Blinded medications were developed and labeled according to the identification (ID) numbers.