Sore ThroatNCT02405832
Zinc Lozenges and Their Effect on Postoperative Sore Throat Syndrome
A study testing Zinc in people with Sore Throat and Post-Operative Sore Throat, run by University of Vermont at 1 site in United States.
Trial summary
The objective of this study is to assess the effect of preoperative administration of oral zinc lozenges on the incidence of postoperative sore throat syndrome. When patients undergo surgery with general anesthesia, they require ventilation of their lungs with the help of a flexible tube (called an endotracheal tube)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sore Throat, Post-Operative Sore Throat
- What is being tested?
- Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 87 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2015to 4 Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ages 18 and older
- American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease)
- Patient coming for elective surgery (except head and neck) requiring general anesthesia
- Patients staying for at least 24 hours postoperatively
- Patients provide informed consent
- Patients presenting for surgery >1 hour in length and <6 hours.
Who cannot join
- History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies
- Chronic smokers
- Patients with Mallampati airway grade of more than 2
- Patients requiring more than one attempt for intubation or traumatic intubations
- Patients requiring laryngeal mask Airway (LMA) placement
- Patients allergic to zinc
Show all 9Show fewer
- Patients requiring quinolones or tetracycline antibiotics pre- or intraoperatively
- Patients undergoing head and neck surgeries
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Zinc Lozenges and Their Effect on Postoperative Sore Throat Syndrome: A Randomized, Double-blinded, Placebo-controlled Prospective Study
The objective of this study is to assess the effect of preoperative administration of oral zinc lozenges on the incidence of postoperative sore throat syndrome.
When patients undergo surgery with general anesthesia, they require ventilation of their lungs with the help of a flexible tube (called an endotracheal tube) that is placed through the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most common consequences is a sore and inflamed throat after the tube is taken out. This is termed postoperative sore throat (POST). Though the intensity and severity of sore throat varies from person to person, the reported incidence is as high as 90% of patients undergoing general anesthesia.
Read more
Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal membranes (which cover the inside of the mouth and throat). The aim of this study is to evaluate the effects of giving zinc lozenges before tube placement on postoperative sore throat.
After written informed consent is received in pre-op, a sealed and coded envelope with either the zinc lozenge or the placebo lozenge will be given to the patient to be administered orally, with the instruction to dissolve the lozenge by sucking on it 30 minutes prior to surgery. Upon completion of surgery and emergence from general anesthesia, the patient will be extubated and transferred to the post-anesthesia care unit (PACU). Once in the PACU, the patient will be assessed regarding the incidence and severity of POST by the study investigator using a standardized scale. The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). This evaluation will be performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery, with the assessment at 4 hours being the primary outcome of the study.
Read the detailed description
The overall purpose of this study is to investigate the effects of preoperative administration of oral zinc lozenges on postoperative sore throat syndrome which consists of pain, dysphagia, and in extreme cases hoarseness. It is associated with coughing (which may increase surgical related pain) and difficulty with oral intake. The study will look at the changes in incidence and severity of POST in the immediate postoperative period.
Postoperative sore throat (POST) syndrome is a very common complication of endotracheal intubation Prior to earlier studies larger endotracheal tubes were utilized for providing general anesthesia. The incidence of POST at that time was 48%, with smaller tubes the incidence decreased to 22%. It is now standard of care to utilize endotracheal tubes based on size and gender of the patient. In subsequent studies to further reduce the incidence of POST, the rate of sore throat in the control groups have been between 17-90%. The cause of POST is related to direct local tissue trauma leading to inflammation of the pharyngeal mucosa and possibly the drying effect of non-humidified gases across the mucous membranes. Although there have been multiple treatments recommended for POST, none of them have been exactly effective, and the symptoms usually ameliorate within 72 hr without treatment. Even though this is the case, it is still recommended to take preventive measures for POST. The presence of POST after surgery is a patient satisfaction issue and has also been associated with a longer stay in in the post anesthesia recovery unit(Higgins et al). Both pharmacologic and non-pharmacologic measures have been recommended in past studies. Nonpharmacological methods for attenuating POST have included using smaller-sized endotracheal tubes, lubricating the endotracheal tube with water-soluble jelly, careful airway instrumentation, and minimizing cuff pressure. Pharmacologic measures have included gargles with lidocaine, aspirin, or ketamine preoperatively, inhalation of beclomethasone or fluticasone propionate, and recently the use of licorice gargle or magnesium lozenges 30 min preoperatively (Ruetzler, Borazan H).
Zinc has been utilized for many years as a topical agent to promote epithelial health and recovery after injury. Several studies have evaluated the effect of zinc on wound healing and epithelial tissue health. These studies have shown that supplementation with zinc sulfate causes rapid recovery of leg and gastric ulcers (Worthington et al). It seems zinc not only increases re-epithelialization, but it also decreases bacterial activity and causes rapid wound healing (Arbabi-kalati et al). Zinc has also been shown to be an immunomodulatory agent that monitors and modifies the immune system and T-lymphocytes. Decreases in zinc serum levels lead to lymphopenia and declines in cellular and humoral immunity. The effect of oral zinc sulfate has also been utilized for treatment of oral wounds by oral surgeons; moreover, research has shown zinc supplementation assists with the recovery of mucosal wounds and treatment of tongue ulcers (Worthington et al). A recent study by Arbabi-kalati, showed that high dose oral zinc sulfate (220 mg TID) decreased the intensity of mucositis, xerostomia, and pain in individuals undergoing chemotherapy or radiotherapy treatments. The mechanism by which zinc improves tissue health was investigated by Sharir et al. and in a model of epithelial injury showed that topical zinc directly activates receptors that promote epithelial repair.
Keeping the above studies in mind, the investigators built this study using the protocols devised by Borazan H, in which they evaluated the efficacy of magnesium lozenges on POST. There are currently no known studies that look at the efficacy of zinc in the prevention of POST. The investigators will use custom compounded lozenges from a local pharmacy with 40 mg of elemental zinc (equivalent to 174 mg of zinc sulfate) per lozenge, which is the tolerable upper intake level for zinc in adults as defined by the US department of Food and Nutrition Board.
The possible knowledge gained from this study for POST syndrome can be extended to people undergoing surgeries requiring endotracheal intubation in the future.
- Conditions
- Sore Throat, Post-Operative Sore Throat
- Being tested
- Zinc, Placebo
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZincDietary supplement
Oral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor
PlaceboDietary supplement
Placebo lozenge, with sweetener and citrus flavor, administered orally
| Study group | Role | What they receive |
|---|---|---|
| Zinc - active arm | Experimental | Oral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor Receives: Dietary Supplement: Zinc |
| Placebo | Placebo comparator | Placebo lozenge, with sweetener and citrus flavor, administered orally Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Post-Operative Sore Throat
The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain).
Measured: 4 hours
Secondary outcomes (3)
Severity of Post-Operative Sore Throat at 30 minutes
The severity of Post-Operative Sore Throat was graded on a 4-point scale ranging from 0 to 3:
0 = no sore throat
- = mild discomfort (patient complains only upon questioning)
- = moderate sore throat (patient complains on their own)
- = severe sore throat (change in voice, hoarseness, and throat pain).
Measured: 30 minutes
Severity of Post-Operative Sore Throat at 2 hours
The severity of Post-Operative Sore Throat was graded on a 4-point scale ranging from 0 to 3:
0 = no sore throat
- = mild discomfort (patient complains only upon questioning)
- = moderate sore throat (patient complains on their own)
- = severe sore throat (change in voice, hoarseness, and throat pain).
Measured: 2 hours
Severity of Post-Operative Sore Throat at 24 hours
The severity of Post-Operative Sore Throat was graded on a 4-point scale ranging from 0 to 3:
0 = no sore throat
- = mild discomfort (patient complains only upon questioning)
- = moderate sore throat (patient complains on their own)
- = severe sore throat (change in voice, hoarseness, and throat pain).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study start10 Mar 2015
- Primary completion4 Apr 2015
- Study completion4 Apr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Sore ThroatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia Grondin, University of Vermont
- Investigators
- Lydia Grondin, M.D., Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02405832
- Sponsor's protocol ID
- CHRMS 14-206
- Status last verified
- Aug 2018
- First submitted
- 27 Mar 2015
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arbabi-kalati F, Arbabi-kalati F, Deghatipour M, Ansari Moghadam A. Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: a double-blind randomized clinical trial. Arch Iran Med. 2012 Jul;15(7):413-7.
PubMed 22724877Borazan H, Kececioglu A, Okesli S, Otelcioglu S. Oral magnesium lozenge reduces postoperative sore throat: a randomized, prospective, placebo-controlled study. Anesthesiology. 2012 Sep;117(3):512-8. doi: 10.1097/ALN.0b013e3182639d5f.
PubMed 22797283Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
PubMed 12066737Ruetzler K, Fleck M, Nabecker S, Pinter K, Landskron G, Lassnigg A, You J, Sessler DI. A randomized, double-blind comparison of licorice versus sugar-water gargle for prevention of postoperative sore throat and postextubation coughing. Anesth Analg. 2013 Sep;117(3):614-621. doi: 10.1213/ANE.0b013e318299a650. Epub 2013 Aug 6.
PubMed 23921656Sharir H, Zinger A, Nevo A, Sekler I, Hershfinkel M. Zinc released from injured cells is acting via the Zn2+-sensing receptor, ZnR, to trigger signaling leading to epithelial repair. J Biol Chem. 2010 Aug 20;285(34):26097-106. doi: 10.1074/jbc.M110.107490. Epub 2010 Jun 3.
PubMed 20522546Worthington HV, Clarkson JE, Bryan G, Furness S, Glenny AM, Littlewood A, McCabe MG, Meyer S, Khalid T. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD000978. doi: 10.1002/14651858.CD000978.pub3.
PubMed 21154347Farhang B, Grondin L. The Effect of Zinc Lozenge on Postoperative Sore Throat: A Prospective Randomized, Double-Blinded, Placebo-Controlled Study. Anesth Analg. 2018 Jan;126(1):78-83. doi: 10.1213/ANE.0000000000002494.
PubMed 28953493
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc Lozenges and Their Effect on Postoperative Sore Throat Syndrome: A Randomized, Double-blinded, Placebo-controlled Prospective Study
- ClinicalTrials.gov ID
- NCT02405832
- Acronym / sponsor ID
- CHRMS 14-206
- Conditions
- Sore Throat, Post-Operative Sore Throat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 10 Mar 2015 (actual)
- Primary completion
- 4 Apr 2015 (actual)
- Study completion
- 4 Apr 2015 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to assess the effect of preoperative administration of oral zinc lozenges on the incidence of postoperative sore throat syndrome.
When patients undergo surgery with general anesthesia, they require ventilation of their lungs with the help of a flexible tube (called an endotracheal tube) that is placed through the mouth, passing the vocal cords, and into the windpipe (trachea). This tube helps oxygenate the patient, delivers anesthetic gas to the lungs, and keeps the airways open to prevent asphyxiation. The procedure is invasive and uncomfortable, and one of the most common consequences is a sore and inflamed throat after the tube is taken out. This is termed postoperative sore throat (POST). Though the intensity and severity of sore throat varies from person to person, the reported incidence is as high as 90% of patients undergoing general anesthesia.
Zinc therapy has been shown in multiple studies to reduce the severity and duration of cold symptoms, and also to up-regulate the immune system. Recent studies have shown that zinc can act as an anti-inflammatory agent and can maintain the integrity of skin and mucosal membranes (which cover the inside of the mouth and throat). The aim of this study is to evaluate the effects of giving zinc lozenges before tube placement on postoperative sore throat.
After written informed consent is received in pre-op, a sealed and coded envelope with either the zinc lozenge or the placebo lozenge will be given to the patient to be administered orally, with the instruction to dissolve the lozenge by sucking on it 30 minutes prior to surgery. Upon completion of surgery and emergence from general anesthesia, the patient will be extubated and transferred to the post-anesthesia care unit (PACU). Once in the PACU, the patient will be assessed regarding the incidence and severity of POST by the study investigator using a standardized scale. The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain). This evaluation will be performed at 30 minutes, 2 hours, 4 hours, and 24 hours post-surgery, with the assessment at 4 hours being the primary outcome of the study.
Detailed description
The overall purpose of this study is to investigate the effects of preoperative administration of oral zinc lozenges on postoperative sore throat syndrome which consists of pain, dysphagia, and in extreme cases hoarseness. It is associated with coughing (which may increase surgical related pain) and difficulty with oral intake. The study will look at the changes in incidence and severity of POST in the immediate postoperative period.
Postoperative sore throat (POST) syndrome is a very common complication of endotracheal intubation Prior to earlier studies larger endotracheal tubes were utilized for providing general anesthesia. The incidence of POST at that time was 48%, with smaller tubes the incidence decreased to 22%. It is now standard of care to utilize endotracheal tubes based on size and gender of the patient. In subsequent studies to further reduce the incidence of POST, the rate of sore throat in the control groups have been between 17-90%. The cause of POST is related to direct local tissue trauma leading to inflammation of the pharyngeal mucosa and possibly the drying effect of non-humidified gases across the mucous membranes. Although there have been multiple treatments recommended for POST, none of them have been exactly effective, and the symptoms usually ameliorate within 72 hr without treatment. Even though this is the case, it is still recommended to take preventive measures for POST. The presence of POST after surgery is a patient satisfaction issue and has also been associated with a longer stay in in the post anesthesia recovery unit(Higgins et al). Both pharmacologic and non-pharmacologic measures have been recommended in past studies. Nonpharmacological methods for attenuating POST have included using smaller-sized endotracheal tubes, lubricating the endotracheal tube with water-soluble jelly, careful airway instrumentation, and minimizing cuff pressure. Pharmacologic measures have included gargles with lidocaine, aspirin, or ketamine preoperatively, inhalation of beclomethasone or fluticasone propionate, and recently the use of licorice gargle or magnesium lozenges 30 min preoperatively (Ruetzler, Borazan H).
Zinc has been utilized for many years as a topical agent to promote epithelial health and recovery after injury. Several studies have evaluated the effect of zinc on wound healing and epithelial tissue health. These studies have shown that supplementation with zinc sulfate causes rapid recovery of leg and gastric ulcers (Worthington et al). It seems zinc not only increases re-epithelialization, but it also decreases bacterial activity and causes rapid wound healing (Arbabi-kalati et al). Zinc has also been shown to be an immunomodulatory agent that monitors and modifies the immune system and T-lymphocytes. Decreases in zinc serum levels lead to lymphopenia and declines in cellular and humoral immunity. The effect of oral zinc sulfate has also been utilized for treatment of oral wounds by oral surgeons; moreover, research has shown zinc supplementation assists with the recovery of mucosal wounds and treatment of tongue ulcers (Worthington et al). A recent study by Arbabi-kalati, showed that high dose oral zinc sulfate (220 mg TID) decreased the intensity of mucositis, xerostomia, and pain in individuals undergoing chemotherapy or radiotherapy treatments. The mechanism by which zinc improves tissue health was investigated by Sharir et al. and in a model of epithelial injury showed that topical zinc directly activates receptors that promote epithelial repair.
Keeping the above studies in mind, the investigators built this study using the protocols devised by Borazan H, in which they evaluated the efficacy of magnesium lozenges on POST. There are currently no known studies that look at the efficacy of zinc in the prevention of POST. The investigators will use custom compounded lozenges from a local pharmacy with 40 mg of elemental zinc (equivalent to 174 mg of zinc sulfate) per lozenge, which is the tolerable upper intake level for zinc in adults as defined by the US department of Food and Nutrition Board.
The possible knowledge gained from this study for POST syndrome can be extended to people undergoing surgeries requiring endotracheal intubation in the future.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zinc - active arm | Experimental | Dietary Supplement: ZincOral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo lozenge, with sweetener and citrus flavor, administered orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women ages 18 and older
- American Society of Anesthesiologists physical status classification system I and II (healthy patient or patient with mild systemic disease)
- Patient coming for elective surgery (except head and neck) requiring general anesthesia
- Patients staying for at least 24 hours postoperatively
- Patients provide informed consent
Key exclusion criteria (9 listed)
- History of preoperative sore throat, common colds, upper respiratory infections, immune deficiencies
- Chronic smokers
- Patients with Mallampati airway grade of more than 2
- Patients requiring more than one attempt for intubation or traumatic intubations
- Patients requiring laryngeal mask Airway (LMA) placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZincOral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor | Dietary supplement | Zinc - active arm |
| PlaceboPlacebo lozenge, with sweetener and citrus flavor, administered orally | Dietary supplement | Placebo |
Primary outcome
Severity of Post-Operative Sore Throat
Time frame: 4 hours
The severity of POST will be graded on a 4-point scale ranging from 0 to 3; 0 being no sore throat, 1 being mild discomfort (complains only upon questioning), 2 being moderate sore throat (complains on his/her own), and 3 being severe sore throat (change in voice, hoarseness, and throat pain).
3 secondary outcomes
Severity of Post-Operative Sore Throat at 30 minutes
Time frame: 30 minutes
Severity of Post-Operative Sore Throat at 2 hours
Time frame: 2 hours
Severity of Post-Operative Sore Throat at 24 hours
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
- Background: PubMed 22724877Arbabi-kalati F, Arbabi-kalati F, Deghatipour M, Ansari Moghadam A. Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: a double-blind randomized clinical trial. Arch Iran Med. 2012 Jul;15(7):413-7.
- Background: PubMed 22797283Borazan H, Kececioglu A, Okesli S, Otelcioglu S. Oral magnesium lozenge reduces postoperative sore throat: a randomized, prospective, placebo-controlled study. Anesthesiology. 2012 Sep;117(3):512-8. doi: 10.1097/ALN.0b013e3182639d5f.
- Background: PubMed 12066737Higgins PP, Chung F, Mezei G. Postoperative sore throat after ambulatory surgery. Br J Anaesth. 2002 Apr;88(4):582-4. doi: 10.1093/bja/88.4.582.
- Background: PubMed 23921656Ruetzler K, Fleck M, Nabecker S, Pinter K, Landskron G, Lassnigg A, You J, Sessler DI. A randomized, double-blind comparison of licorice versus sugar-water gargle for prevention of postoperative sore throat and postextubation coughing. Anesth Analg. 2013 Sep;117(3):614-621. doi: 10.1213/ANE.0b013e318299a650. Epub 2013 Aug 6.
- Background: PubMed 20522546Sharir H, Zinger A, Nevo A, Sekler I, Hershfinkel M. Zinc released from injured cells is acting via the Zn2+-sensing receptor, ZnR, to trigger signaling leading to epithelial repair. J Biol Chem. 2010 Aug 20;285(34):26097-106. doi: 10.1074/jbc.M110.107490. Epub 2010 Jun 3.
- Background: PubMed 21154347Worthington HV, Clarkson JE, Bryan G, Furness S, Glenny AM, Littlewood A, McCabe MG, Meyer S, Khalid T. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD000978. doi: 10.1002/14651858.CD000978.pub3.
- Derived from this study: PubMed 28953493Farhang B, Grondin L. The Effect of Zinc Lozenge on Postoperative Sore Throat: A Prospective Randomized, Double-Blinded, Placebo-Controlled Study. Anesth Analg. 2018 Jan;126(1):78-83. doi: 10.1213/ANE.0000000000002494.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia Grondin, M.D. principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc in people with Sore Throat and Post-Operative Sore Throat, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Post-Operative Sore Throat (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02405832, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2018.