Triple blind randomised control trial of two different treatment analgesic regimens following open reduction and internal fixation of mandibular fractures.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Pain
Study Overview
Brief Summary
The mandible is one of the most frequently fractured bones in the facial skeleton. Restoration of normal occlusion, bite function, and facial symmetry are the goals of mandibular fracture treatment. Successful treatment is also judged by the avoidance of functional limitations, including pain with mouth opening, impairment of jaw movements, or any healing complications. Postoperative pain control is an important outcome in assessing overall treatment success and patient satisfaction.High levels of acute postoperative pain have been reported to be associated with slower recovery of function and increased length of hospital stay. The availability of a wider selection of analgesics allows options that can provide better efficacy, and safer profile of adverse effects. A study of pain as an outcome after surgery ideally reports the specific type of analgesics given, uses validated pain assessments, and reports adverse effects related to the agent prescribed. Multiple oral health–related quality-of-life (QOL) instruments have been developed that are generic, organ specific, or condition specific and have been used in studies of patients who have had mandibular surgery.
Thus, this study is aimed to compare efficacy of two analgesics in pain control following open reduction and internal fixation of mandibular fractures.
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 15.00 Year(s) to 55.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •ASA I, II AND III.
- •Mandibular fractures not associated with any acute infection.
Exclusion Criteria
- •Patient with any systemic illness like cardiologic and neurologic disorders.
- •Patient with pathologic fractures, osteoradionecrosis, strictly non-operable cases and other facial fractures.
Outcomes
Primary Outcomes
Pain
Time Frame: Postoperative day 1 and day 2
Secondary Outcomes
No secondary outcomes reported
