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A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy

A Study on Early Sucking of Lollipops in Preschool Children After Adenotonsillectomy:a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06662968
Enrollment
186
Registered
2024-10-29
Start date
2024-10-21
Completion date
2025-04-28
Last updated
2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adenotonsillectomy

Keywords

Lollipops, Adenotonsillectomy

Brief 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 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.

Interventions

OTHERLollipop group

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.

OTHERControl group

In the Control group,children were sent to the recovery room (PACU) for observation after extubation after surgery.They were received routine nursing treatment.

Sponsors

Maternal and Child Health Hospital of Hubei Province
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

Inclusion criteria

* patients who choose to have adenotonsillectomy surgery * the American Society of Anesthesiologists (ASA) physical status ranked I-II * competent to provide informed consent

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Postoperative agitation scoreTime Frame: intraoperative period,10 minutes-1 hoursPostoperative 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 vomitingPostoperative 1 minute-5hoursIncidence of nausea and vomiting will be recorded during the time of the recovery room and four hours after returning to the ward .

Secondary

MeasureTime frameDescription
Spo2Postoperative 1 minute - 5hoursSpo2 will be continuous monitoring and recorded during the time of the recovery room
other adverse reactionsPostoperative 10 minutes - 3daysThe occurrence of adverse reactions( wound infection and others) were continuous monitoring and recorded after the operation
the time of leaving the recovery room and the hospitalPostoperative 1 hour - 3daysthe time of leaving the recovery room and the hospital will be recorded
family satisfactionPostoperative 5 hoursRecord the satisfaction of the parents with this operation ,defined as a score out of 100

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026