Postoperative PainNCT03296020
The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
A study testing HONEY in people with Postoperative Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The aim of this study is to investigate the effect of honey administration on pain following pediatric tonsillectomy or adenotonsilectomy. The patients( children 2-18 years old) will divide into two groups by simple randomization method( the control group and the case group). Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- HONEY
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Nov 2017to 1 Oct 2018
- 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 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- children ages 2-18 years old that candidates for Tonsillectomy with or without adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula.
- Parents' signature on informed consent form.
Who cannot join
- Allergy to honey
- Allergy to Acetaminophen
- Patients with Diabeties mellitus
- pregnent/breast feeding patients
- patients with coagulation disorders
- patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
HaEmek Medical Center
Afula
Tzvi chen, MD, 972546151054, TZVIKACHEN@GMAIL.COM
About this study
The aim of this study is to investigate the effect of honey administration on pain following pediatric tonsillectomy or adenotonsilectomy.
The patients( children 2-18 years old) will divide into two groups by simple randomization method( the control group and the case group).
Read more
After surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup+ syrup oxycode( as necessary).
the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).
The families would ask to follow treatment protocols for 7 days. From the first to the 7th day after the operation , the parents would ask to fill a questionnaire every day for assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken daily, the number of times the child awaking at night due to pain, the amount of fluids intake daily, the time of commencement of regular oral intake.
patient would follow up 7-14 days after surgery.
Read the detailed description
This study was approved by the regional ethics committe of the Hospital. The participants would be: Children (2-18 years old, male and female), who will have the indication of tonsillectomy and will undergo classic tonsillectomy with or without adenoidectom in otolaryngology departement in HaEmek Hospital and they ate already honey in their lives.
Exclusion criteria:
- Allergy to honey
- Allergy to Acetaminophen
- Patients with Diabeties mellitus
- pregnent/breast feeding patients
- patients with coagulation disorders
- patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery).
- Conditions
- Postoperative Pain
- Being tested
- HONEY
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HONEYOther
100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | After the surgery, during the hospitalization ,the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary). After the discharge from the hospital - the patients would take( as is customary in our ENT department): acetaminophen syrup ( as necessary) and other painkillers ( as necessary). The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days. |
| case group-"HONEY" | Experimental | After the surgery, during the hospitalization ,the case group would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup + syrup oxycode( as necessary).
After the discharge from the hospital - the patients would take:acetaminophen syrup ( as necessary) and other painkillers+honey twice a day( 5 ml- one tea spoon each time) .
The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days. Receives: Other: HONEY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
pain intensity by visual analouge scale(VAS), the numbers of painkillers taken daily, the number of times the child awaking at night due to pain
Measured: 7 days
Amount of fluids
what is the amount of fluids intake daily
Measured: 7 days
The time of commencement of regular oral intake.
How long is take post surgery for the child to return to his regular oral intake
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start1 Nov 2017
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Oct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized clinical trials that included 2 armes: the control group and the case group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- tzvi chen, Study chair, haemek medical centertzvi chen, Study director, haemek medical centerTZVI CHEN, Principal investigator, haemek medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03296020
- Sponsor's protocol ID
- 0079-17-EMC
- Status last verified
- Feb 2018
- First submitted
- 25 Sep 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Honey on Improving the Post Surgical Course After Tonsillectomy in Children-prospective Study
- ClinicalTrials.gov ID
- NCT03296020
- Acronym / sponsor ID
- 0079-17-EMC
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Oct 2018 (estimated)
- First posted
- 28 Sep 2017 (actual)
- 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 aim of this study is to investigate the effect of honey administration on pain following pediatric tonsillectomy or adenotonsilectomy.
The patients( children 2-18 years old) will divide into two groups by simple randomization method( the control group and the case group).
After surgery the case group: would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup+ syrup oxycode( as necessary).
the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary).
The families would ask to follow treatment protocols for 7 days. From the first to the 7th day after the operation , the parents would ask to fill a questionnaire every day for assessment of pain intensity by visual analouge scale(VAS) , the numbers of painkillers taken daily, the number of times the child awaking at night due to pain, the amount of fluids intake daily, the time of commencement of regular oral intake.
patient would follow up 7-14 days after surgery.
Detailed description
This study was approved by the regional ethics committe of the Hospital. The participants would be: Children (2-18 years old, male and female), who will have the indication of tonsillectomy and will undergo classic tonsillectomy with or without adenoidectom in otolaryngology departement in HaEmek Hospital and they ate already honey in their lives.
Exclusion criteria:
- Allergy to honey
- Allergy to Acetaminophen
- Patients with Diabeties mellitus
- pregnent/breast feeding patients
- patients with coagulation disorders
- patients who undrego another operation in addition to tonsillectomy with or without adenoidectomy ( except insertion of ventilation tubes surgery).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized clinical trials that included 2 armes: the control group and the case group
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –After the surgery, during the hospitalization ,the control group would get as is customary in our ENT department :acetaminophen syrup+ syrup oxycode( as necessary). After the discharge from the hospital - the patients would take( as is customary in our ENT department): acetaminophen syrup ( as necessary) and other painkillers ( as necessary). The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days. |
| case group-"HONEY" | Experimental | Other: HONEYAfter the surgery, during the hospitalization ,the case group would instructed to use honey twice a day( 5 ml- one tea spoon each time)+acetaminophen syrup + syrup oxycode( as necessary). After the discharge from the hospital - the patients would take:acetaminophen syrup ( as necessary) and other painkillers+honey twice a day( 5 ml- one tea spoon each time) . The families would ask to follow treatment protocols for 7 days and will fill a questionnarie every day during the 7 days. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- children ages 2-18 years old that candidates for Tonsillectomy with or without adenoidectomy surgery, in otolaryngolgy department , HaEmek Hospital, Afula.
- Parents' signature on informed consent form.
Key exclusion criteria (6 listed)
- Allergy to honey
- Allergy to Acetaminophen
- Patients with Diabeties mellitus
- pregnent/breast feeding patients
- patients with coagulation disorders
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 |
|---|---|---|
| HONEY100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL | Other | case group-"HONEY" |
Primary outcome
Pain intensity
Time frame: 7 days
pain intensity by visual analouge scale(VAS), the numbers of painkillers taken daily, the number of times the child awaking at night due to pain
Amount of fluids
Time frame: 7 days
what is the amount of fluids intake daily
The time of commencement of regular oral intake.
Time frame: 7-14 days
How long is take post surgery for the child to return to his regular oral intake
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Individual participant dataSharing planned: Undecided
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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.
tzvi chen study chair
haemek medical center
tzvi chen study director
haemek medical center
TZVI CHEN principal investigator
haemek medical center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HONEY in people with Postoperative Pain, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 28 Feb 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 Israel. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tzvi Chen, MD (972-546151054, tzvikachen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 7 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2018.