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

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 Overview

• Status: Completed
• Conditions: Adenotonsillectomy
• Intervention / Treatment: Other: Lollipop group; Other: Control group

• Study Type: Interventional
• Enrollment (Actual): 186
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Maternal and Child Health Hospital of Hubei Province

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lollipop group; Lollipop group patients were given lollipops for sucking in the PACU	Other: Lollipop 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.
Active Comparator: Control group; Control group patients were received routine nursing treatment in the PACU.	Other: Control 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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 .	Postoperative 1 minute-5hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spo2	Spo2 will be continuous monitoring and recorded during the time of the recovery room	Postoperative 1 minute - 5hours
other adverse reactions	The occurrence of adverse reactions( wound infection and others) were continuous monitoring and recorded after the operation	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	Postoperative 1 hour - 3days
family satisfaction	Record the satisfaction of the parents with this operation ,defined as a score out of 100	Postoperative 5 hours

Collaborators and Investigators

• Sponsor: Maternal and Child Health Hospital of Hubei Province
• Investigators: Principal Investigator: Na Li, MD, Maternal and Child Health Hospital of Hubei Province

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2024
• Primary Completion (Actual): April 28, 2025
• Study Completion (Actual): April 28, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 26, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Adenotonsillectomy; Lollipops
• Other Study ID Numbers: MCHH_006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No