Effects of Flurbiprofen Spray and Ice Cream for Pain and Voice Outcomes After Thyroidectomy

NCT07531147 | Not Yet Recruiting Phase 4

• 1 other identifier: IzmirKCU-KARAISLI-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Thyroidectomy; Sore Throat; Voice Quality

Keywords

thyroidectomy; sore throat; voice quality; flurbiprofen; ice cream

Outcome Measures

Primary Outcomes (2)

• 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.

  From enrollment to the postoperative sixth hour.

• 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.

  From enrollment to the postoperative sixth hour.

Study Arms (3)

Oral flurbiprofen (0.25%) spray group

ACTIVE COMPARATOR

This group will receive one puff of oral flurbiprofen (0.25%) spray (for pain palliation) at 5 hours post-operatively

Drug: Flurbiprofen

Ice cream group

ACTIVE COMPARATOR

This group will receive 105 ml of frozen ice cream at 5 hours post-operatively

Dietary Supplement: Food Effect cohort

Placebo group

PLACEBO COMPARATOR

This group will receive one puff of spray prepared with drinking water at 5 hours post-operatively as a placebo.

Drug: Placebo Control

Interventions

Food Effect cohort DIETARY_SUPPLEMENT

This group will receive 105 ml of frozen ice cream at 5 hours post-operatively

Ice cream group

Placebo Control DRUG

This group will receive one puff of spray prepared with drinking water at 5 hours post-operatively as a placebo.

Placebo group

Flurbiprofen DRUG

This group will receive one puff of oral flurbiprofen (0.25%) spray (for pain palliation) at 5 hours post-operatively.

Oral flurbiprofen (0.25%) spray group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history of neck surgery
• Age between 18-85 years
• Undergoing thyroidectomy
• Agreeing to participate in the study
• Operation duration between 60-120 minutes

You may not qualify if:

• 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
• Pre-operative laryngeal pathology
• Being under 18 years of age
• Refusal to participate in the study
• Smoking
• Flurbiprofen allergy
• Lactose intolerance

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Celebi University

Izmir, 35620, Turkey (Türkiye)

Location

Related Publications (2)

• Turk B, Akpinar M, Erol ZN, Kaya KS, Unsal O, Coskun BU. The effect of flurbiprofen oral spray and ibuprofen vs ibuprofen alone on postoperative tonsillectomy pain: An open, randomised, controlled trial. Clin Otolaryngol. 2018 Jun;43(3):835-840. doi: 10.1111/coa.13058. Epub 2018 Jan 18.

  PMID: 29288561 BACKGROUND

• Muderris T, Tezcan G, Sancak M, Gul F, Ugur G. Oral flurbiprofen spray for postoperative sore throat and hoarseness: a prospective, randomized, double-blind, placebo-controlled study. Minerva Anestesiol. 2019 Jan;85(1):21-27. doi: 10.23736/S0375-9393.18.12703-9. Epub 2018 May 14.

  PMID: 29756749 BACKGROUND

MeSH Terms

Conditions

Pharyngitis

Interventions

Flurbiprofen

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Serkan KARAISLI, Asc.Professor, MD, FEBS (End.)

  Izmir Katip Celebi University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Serkan KARAISLI, Asc.Professor, MD, FEBS (End.)

CONTACT

00 90 555 373 8550; skaraisli@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, MD, F.E.B.S (End.)

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 15, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)