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

NCT06662968 | Completed

• 1 other identifier: MCHH_006
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenotonsillectomy

Keywords

Lollipops; Adenotonsillectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Spo2

  Postoperative 1 minute - 5hours

• other adverse reactions

  Postoperative 10 minutes - 3days

• the time of leaving the recovery room and the hospital

  Postoperative 1 hour - 3days

• family satisfaction

  Postoperative 5 hours

Study Arms (2)

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.

Interventions

Lollipop group OTHER

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 group OTHER

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

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Maternal and Child Health Hospital of Hubei Province: lead

Study Sites (1)

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Na Li, MD

  Maternal and Child Health Hospital of Hubei Province

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 29, 2024
• Study Start: October 21, 2024
• Primary Completion: April 28, 2025
• Study Completion: April 28, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)