Ibuprofen as a Pain Management in Pediatric Dentistry
Condition: Pain Management
Study type: Interventional
Phase: Phase 3

Summary: 
      Abstract Introduction: Administration of non-steroidal anti-inflammatory drugs (NSAIDs)
      before tooth extraction may reduce post-surgical pain, but there is a lack of research.

      Aims: To compare pain and anxiety in pediatric tooth extraction patients receiving a
      preoperative NSAID vs. placebo.

      Design: Randomized, double-blind, placebo-controlled clinical trial. Setting: Princess Nourah
      Bint Abdulrahman University's (PNU's) dental clinic in Riyadh, Saudi Arabia.

      Materials and Methods: Eligible pediatric tooth extraction patients were randomized to Group
      A, which received NSAID preoperatively, or Group B, which received placebo.

      Interventions: A research coordinator (RC) measured participants prior to extraction, and 3-
      and 24-hours post-extraction.

      Main Outcome Methods: The Wong-Baker FACES scale (WBFS) and the Modified Child Dental Anxiety
      Scale - Faces (MCDASf).
    

Detailed description: 
      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.

      Once participants underwent consent, they were assigned an ID number which placed them in a
      randomized group. The clinician used the medication associated with the participant's ID
      number prior to extraction. At this point, baseline data was gathered, which included the
      following variables: patient gender, patient age, anesthesia technique used (infiltration for
      upper mouth extractions, and nerve block for lower mouth extractions), number of teeth being
      extracted, baseline self-reported pain measurement, and baseline self-reported anxiety
      measurement.

      Interventions Administration of Study Drug Once placed in a randomization group, the study
      drug was administered. Those randomized to Group A (active) received the NSAID in the study,
      which was oral commercially-available Nurfen® syrup containing the NSAID ibuprofen. Between
      7.5 to 15 ml/kg was administered, depending on the child's age. Those randomized to Group B
      (control) were given a colored, flavored solution as a placebo.

      Tooth Extraction After administration of the study drug and baseline data collection, the
      treating clinicians (n=6) followed a standard protocol for the study. Clinicians had 1 to 5
      years of experience. No formal calibration was done, and behavioral management techniques
      were included in the standard protocol. They reviewed the participant's medical and dental
      histories and noted any allergies. After a thorough clinical and radiographic examination,
      they applied topical anesthesia, then administered local anesthesia with dosage appropriate
      to the patient's age and weight (Lidocaine 2% with epinephrine 1:100,000). After local
      anesthesia, the efficacy of the anesthesia was tested subjectively and objectively, then
      pediatric forceps were used for the extraction(s). This was followed by the application of a
      gauze pressure pack, and verbal and written post-extraction instructions were provided to the
      child and parent.

      Main Outcome Methods Data Collection Two instruments were used for outcome measurement: the
      Wong-Baker FACES scale (WBFS) for pain perception, and the Modified Child Dental Anxiety
      Scale - Faces (MCDASf) for anxiety. Both the WBFS and MCDASf were administered at baseline
      (immediately after consent), and at 3- and 24-hours post-extraction. It was estimated that
      3-hours post-extraction, local analgesic would have worn off and pain would typically be at
      its peak.

      The baseline measurements were done in person by the RC, and both the 3- and 24-hour
      follow-up measurements were conducted by the RC by phone. As both WBFS and MCDASf are visual
      scales, forms were provided to the parent at the appointment which were then completed with
      the child during the follow-up calls and sent to the RC in the mail. During the follow-up
      phone calls, the researcher would talk on the phone to the parent, and coach them to ask the
      child the questions and have the child answer them by pointing to the visual scale. The
      parent would the relay the child's answer to the researcher for the record.

      Measurements Intended for pediatrics patients, the WBFS has patients assign a score of 0, 2,
      4, 6, 8, and 10 to indicate their level of perceived pain.

      The MCDASf scale was developed and validated to measure dental-related anxiety in children
      about eight different topics; only "How do you feel about having a tooth taken out?" was
      asked in this study. Respondents assign a score between 1 and 5 corresponding to their level
      of anxiety about the topic .
    

Intervention name(s): IBUPROFEN
Intervention type(s): Drug
Intervention description(s): given to children 30 minutes before extraction / orally for one time only
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled clinical trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention