AdenotonsillectomyNCT06662968
A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy
A study testing Lollipop group in people with Adenotonsillectomy, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
Trial summary
The aim of this study is to observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and… Read more about this study
- Who is it for?
- Ages 2 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Adenotonsillectomy
- What is being tested?
- Lollipop group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2024to 28 Apr 2025
- 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 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients who choose to have adenotonsillectomy surgery
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- competent to provide informed consent
Who cannot join
- psychiatric disorders
- upper respiratory tract infection
- high risk of reflux aspiration
- carbohydrate malabsorption syndrome and other endocrine or genetic metabolic diseases (contraindications of lollipop ingredients)
Trial locations and contacts
1 site in 1 country.
China1 site
Maternal and Child Health Hospital of Hubei Province
Wuhan, Hubei, 430000
About this study
Official title: A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy:a Randomized Controlled Trial
The aim of this study is to observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and postoperative wound recovery rate.
Participants will be randomly allocated to two groups:a lollipop sucking group (Group A) and a control group (Group B), Two groups of children were sent to the recovery room (PACU) for observation after extubation . Group A patients were given lollipops for sucking after waking up, while Group B received routine nursing treatment.
The goal of this clinical trial is to explore whether lollipops have advantages in early postoperative feeding and alleviating postoperative agitation in children, and to provide reliable clinical evidence for the consumption of lollipops after surgery.
- Conditions
- Adenotonsillectomy
- Being tested
- Lollipop group, Control group
- Keywords
- Lollipops, Adenotonsillectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lollipop groupOther
In the Lollipop group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were given lollipops for sucking without chewing after waking up.Throughout the entire sucking process, we continuously monitor vital signs.
Control groupOther
In the Control group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were received routine nursing treatment.
| Study group | Role | What they receive |
|---|---|---|
| Lollipop group | Experimental | Lollipop group patients were given lollipops for sucking in the PACU |
| Control group | Active comparator | Control group patients were received routine nursing treatment in the PACU. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative agitation score
Postoperative agitation score will be recorded at 6 time points, including the time of entering the recovery room (Time 0), when the lollipop is given (Time 1), when the lollipop is given for 10 minutes(Time 2), when the lollipop is given for 20 minutes(Time 3), when the lollipop is given for 30 minutes(Time 4) and leave the recovery room (T5).
Measured: Time Frame: intraoperative period,10 minutes-1 hours
Incidence of nausea and vomiting
Incidence of nausea and vomiting will be recorded during the time of the recovery room and four hours after returning to the ward .
Measured: Postoperative 1 minute-5hours
Secondary outcomes (4)
Spo2
Spo2 will be continuous monitoring and recorded during the time of the recovery room
Measured: Postoperative 1 minute - 5hours
other adverse reactions
The occurrence of adverse reactions( wound infection and others) were continuous monitoring and recorded after the operation
Measured: Postoperative 10 minutes - 3days
the time of leaving the recovery room and the hospital
the time of leaving the recovery room and the hospital will be recorded
Measured: Postoperative 1 hour - 3days
family satisfaction
Record the satisfaction of the parents with this operation ,defined as a score out of 100
Measured: Postoperative 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start21 Oct 2024
- Primary completion28 Apr 2025
- Study completion28 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdenotonsillectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternal and Child Health Hospital of Hubei Province
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Na, Maternal and Child Health Hospital of Hubei Province
- Investigators
- Na Li, MD, Principal investigator, Maternal and Child Health Hospital of Hubei Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06662968
- Sponsor's protocol ID
- MCHH_006
- Status last verified
- Jun 2025
- First submitted
- 21 Oct 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy:a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06662968
- Acronym / sponsor ID
- MCHH_006
- Conditions
- Adenotonsillectomy
- Keywords
- Lollipops, Adenotonsillectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Maternal and Child Health Hospital of Hubei ProvinceUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 28 Apr 2025 (actual)
- Study completion
- 28 Apr 2025 (actual)
- First posted
- 29 Oct 2024 (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 observe the consumption effect of early lollipop sucking in preschool children after adenotonsillectomy through clinical experiments, and to explore the impact of early postoperative lollipop consumption on postoperative agitation, incidence of postoperative nausea and vomiting, and postoperative wound recovery rate.
Participants will be randomly allocated to two groups:a lollipop sucking group (Group A) and a control group (Group B), Two groups of children were sent to the recovery room (PACU) for observation after extubation . Group A patients were given lollipops for sucking after waking up, while Group B received routine nursing treatment.
The goal of this clinical trial is to explore whether lollipops have advantages in early postoperative feeding and alleviating postoperative agitation in children, and to provide reliable clinical evidence for the consumption of lollipops after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lollipop group | Experimental | –Lollipop group patients were given lollipops for sucking in the PACU |
| Control group | Active comparator | –Control group patients were received routine nursing treatment in the PACU. |
Who may qualify
- Ages
- 2 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patients who choose to have adenotonsillectomy surgery
- the American Society of Anesthesiologists (ASA) physical status ranked I-II
- competent to provide informed consent
Key exclusion criteria (4 listed)
- psychiatric disorders
- upper respiratory tract infection
- high risk of reflux aspiration
- carbohydrate malabsorption syndrome and other endocrine or genetic metabolic diseases (contraindications of lollipop ingredients)
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 |
|---|---|---|
| Lollipop groupIn the Lollipop group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were given lollipops for sucking without chewing after waking up.Throughout the entire sucking process, we continuously monitor vital signs. | Other | – |
| Control groupIn the Control group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were received routine nursing treatment. | Other | – |
Primary outcome
Postoperative agitation score
Time frame: Time Frame: intraoperative period,10 minutes-1 hours
Postoperative agitation score will be recorded at 6 time points, including the time of entering the recovery room (Time 0), when the lollipop is given (Time 1), when the lollipop is given for 10 minutes(Time 2), when the lollipop is given for 20 minutes(Time 3), when the lollipop is given for 30 minutes(Time 4) and leave the recovery room (T5).
Incidence of nausea and vomiting
Time frame: Postoperative 1 minute-5hours
Incidence of nausea and vomiting will be recorded during the time of the recovery room and four hours after returning to the ward .
4 secondary outcomes
Spo2
Time frame: Postoperative 1 minute - 5hours
other adverse reactions
Time frame: Postoperative 10 minutes - 3days
the time of leaving the recovery room and the hospital
Time frame: Postoperative 1 hour - 3days
family satisfaction
Time frame: Postoperative 5 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 12 Jun 2025.
- Individual participant dataSharing planned: Yes
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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.
Na Li, MD principal investigator
Maternal and Child Health Hospital of Hubei Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lollipop group in people with Adenotonsillectomy, run by Maternal and Child Health Hospital of Hubei Province at 1 site in China.
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 3 inclusion and 4 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 12 Jun 2025. 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 China. 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?
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?
Postoperative agitation score (time frame: Time Frame: intraoperative period,10 minutes-1 hours). The study lists 2 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 12 Jun 2025.