Effects of Flurbiprofen Spray and Ice Cream for Pain and Voice Outcomes After Thyroidectomy
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorIzmir Katip Celebi University
About this trial
Researchers will compare oral flurbiprofen (%0.25) spray and ice cream to a placebo (a look-alike substance that contains no drug) to see if oral flurbiprofen (%0.25) spray and ice cream works to effect post-thyroidectomy throat pain and voice quality.
Participants will:
* Receive 1 puff of oral flurbiprofen (0.25%) spray or 105 ml of ice cream or 1 puff of oral spray prepared with drinking water (placebo) at 5 hours postoperatively according to randomization result * Undergo voice analysis using Praat voice analysis (University of Amsterdam) at 6 hours postoperatively * Undergo a visual analog scale for analgesia status at 6 hours postoperatively
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
No history of neck surgery
Age between 18-85 years
Undergoing thyroidectomy
Agreeing to participate in the study
Disqualifiers
History of neck surgery
History of radiotherapy to the head and neck region
Pre-operative or post-operative vocal cord paralysis
Pre-operative phonetic disorder
Trial design
Design model
Parallel
Treatments tested in this trial
Flurbiprofen
DrugThis group will receive one puff of oral flurbiprofen (0.25%) spray (for pain palliation) at 5 hours post-operatively.
Food Effect cohort
Dietary supplementThis group will receive 105 ml of frozen ice cream at 5 hours post-operatively
Placebo Control
DrugThis group will receive one puff of spray prepared with drinking water at 5 hours post-operatively as a placebo.
Treatment groups
100 Participants
are divided into 3 treatment groupsGroup A: Oral flurbiprofen (0.25%) spray groupActive comparator 1 intervention
Group B: Ice cream groupActive comparator 1 intervention
Group C: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of flurbiprofen (0.25%) spray and ice cream on voice quality
To compare the effects of flurbiprofen (0.25%) spray and ice cream on voice quality (Praat voice analysis) in patients who underwent thyroidectomy, compared to a placebo group and each other.
Time frame
From enrollment to the postoperative sixth hour.2
Feasibility of flurbiprofen (0.25%) spray and ice cream on pain palliation
To compare the effects of flurbiprofen (0.25%) spray and ice cream on pain palliation in patients who underwent thyroidectomy, compared to a placebo group and each other.
Time frame
From enrollment to the postoperative sixth hour.Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: