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

Not Applicable

Recruiting

• Conditions: Adenotonsillectomy

• Registration Number: NCT06662968
• Lead Sponsor: Maternal and Child Health Hospital of Hubei Province

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-21
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-26
• Study First Posted: 2024-10-29
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-20
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Incidence of nausea and vomiting	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 .
Postoperative agitation score	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).

Secondary Outcome Measures

Name	Time	Method
the time of leaving the recovery room and the hospital	Postoperative 1 hour - 3days	the time of leaving the recovery room and the hospital will be recorded
family satisfaction	Postoperative 5 hours	Record the satisfaction of the parents with this operation ,defined as a score out of 100
Spo2	Postoperative 1 minute - 5hours	Spo2 will be continuous monitoring and recorded during the time of the recovery room
other adverse reactions	Postoperative 10 minutes - 3days	The occurrence of adverse reactions( wound infection and others) were continuous monitoring and recorded after the operation

Trial Locations

Locations (1)

Maternal and Child Health Hospital of Hubei Province; 🇨🇳 Wuhan, Hubei, China