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Clinical Trials/CTRI/2018/02/012260
CTRI/2018/02/012260CompletedNot Applicable

Triple blind randomised control trial of two different treatment analgesic regimens following open reduction and internal fixation of mandibular fractures.

SDM College of Dental Sciences and Hospital1 site in 1 country100 target enrollmentStarted: January 11, 2015Last updated:

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

Investigators

Sponsor
SDM College of Dental Sciences and Hospital
Sponsor Class
Other [Private Dental College- SDM College of Dental Sciences and Hospital]

Study Sites (1)

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