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NCT Number: NCT06662968

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

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.

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Key information

Conditions

Adenotonsillectomy

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maternal and Child Health Hospital of Hubei Province

Wuhan, Hubei, 430000, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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).

  2. 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 .

Secondary outcomes

  1. Spo2

    Time frame: Postoperative 1 minute - 5hours

    Spo2 will be continuous monitoring and recorded during the time of the recovery room

  2. other adverse reactions

    Time frame: Postoperative 10 minutes - 3days

    The occurrence of adverse reactions( wound infection and others) were continuous monitoring and recorded after the operation

  3. the time of leaving the recovery room and the hospital

    Time frame: Postoperative 1 hour - 3days

    the time of leaving the recovery room and the hospital will be recorded

  4. family satisfaction

    Time frame: Postoperative 5 hours

    Record the satisfaction of the parents with this operation ,defined as a score out of 100

Sponsors and collaborators

Lead sponsor

Maternal and Child Health Hospital of Hubei Province

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 29, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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