Ibuprofen Versus Ibuprofen/Acetaminophen Postoperatively in Patients Needing Root Canal Therapy
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Aim: The purpose of this study was to compare ibuprofen versus an ibuprofen/acetaminophen
      combination for postoperative pain control in patients requiring root canal treatment with a
      tooth that is painful to cold and biting.

      Methodology: Following regular root canal treatment, patients randomly received identical
      appearing tablets of 600 mg ibuprofen or 600 mg ibuprofen/650 mg acetaminophen to be taken
      every 6 hours as needed for pain. A 4-day diary was used to record pain and medication use.
    

Detailed description: 
      This was a single-center, double-blind, interventional trial where (randomly) one group
      received ibuprofen and the other group received ibuprofen and acetaminophen.

      Before the experiment, the ibuprofen and ibuprofen/acetaminophen groups were assigned 6-digit
      random numbers. The number assignment determined which drug regimen would be administered
      postoperatively for each patient. Only the random numbers were recorded on the data
      collection sheet in order to maintain blinding of the experiment.

      The blinding of the ibuprofen and ibuprofen/acetaminophen medications was done as follows. A
      registered pharmacist compounded identical appearing tablets of 200 mg ibuprofen and tablets
      of 200 mg ibuprofen/216.7 mg acetaminophen. The tablets were placed in identical-appearing
      bottles (60 tabs of 200 mg ibuprofen or 60 tabs of a combination of 200 mg ibuprofen/216.7 mg
      acetaminophen). The pharmacist prepared the master code sheet and assigned the random numbers
      to the bottles. Therefore, the medication was blind to both the patient and the operator. A
      copy of the master list of random numbers was supplied by the compounding pharmacist solely
      to the lead researcher and was not made available to anyone else during the data collection
      period.

      At the end of the debridement appointment, the patient received either a bottle containing 60
      tabs of 200 mg ibuprofen or 60 tabs of 200 mg ibuprofen/216.7 mg acetaminophen. The patients
      were instructed to take 3 tablets every 6 hours as needed for pain.

      The patients received a diary for 4 days post-treatment to record pain, percussion pain, and
      the amount and type of study medications taken. Patients were instructed to tap on the tooth
      that had emergency endodontic treatment and record this as their percussion pain. Patients
      recorded their pain levels on a VAS as described earlier for postoperative treatment pain.
      Starting on the morning after their appointment, patients also recorded the number of study
      medications taken within each 24-hour period.
    

Intervention name(s): Ibuprofen 600 mg; ibuprofen 600 mg and acetaminophen 650 mg
Intervention type(s): Drug; Drug
Intervention description(s): identical appearing tablets containing 600 mg of ibuprofen; identical appearing tablets of the combination of ibuprofen and acetaminophen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment