CompletedPhase 4

Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

China130 participantsStarted 2019-01-04

Plain-language summary

Tonsillectomy and adenoidectomy is one of the most common pediatric surgeries, and agitation and severe postoperative pain have been considered a very common complications. Dexmedetomidine mainly inhibits the release of norepinephrine by acting on the α-adrenergic receptor of the brainstem nucleus, which can produce good sedative effects. Hydromorphone has a longer duration of action than fentanyl, and it also has a certain sedative effect. The combination of the two is more conducive to the management of postanesthetic agitation and pain. This study was to compare the effect of different doses of dexmedetomidine combined with hydromorphone in the sedation and analgesia after pediatric tonsillectomy and adenoidectomy.

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * experienced tonsillectomy and adenoidectomy * ASA physical status I-II * weight 12-30 kg Exclusion Criteria: * respiratory disease * circulatory or nervous system disease * hepatic dysfunction * known adverse reactions to hydromophine and dexmedetomidine

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

extubation time

Timeframe: duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins

Agitation scores

Timeframe: scores at the time point of 0 minute after extubation

Agitation scores

Timeframe: scores at the time point of 5 minutes after extubation

Agitation scores

Timeframe: scores at the time point of 10 minutes after extubation

Agitation scores

Timeframe: scores at the time point of 15 minutes after extubation

coughing score

Timeframe: scores at the time point of 0 minute after extubation

coughing score

Timeframe: scores at the time point of 5 minutes after extubation

Trial details

NCT IDNCT03760809

SponsorEye & ENT Hospital of Fudan University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-02-10

View on ClinicalTrials.gov More Agitated; State, Acute Reaction to Stress trials

Plain-language summary

Who can participate

Age range

3 Years – 10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

extubation time

Timeframe: duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins

Agitation scores

Timeframe: scores at the time point of 0 minute after extubation

Agitation scores

Timeframe: scores at the time point of 5 minutes after extubation

Agitation scores

Timeframe: scores at the time point of 10 minutes after extubation

Agitation scores

Timeframe: scores at the time point of 15 minutes after extubation

coughing score

Timeframe: scores at the time point of 0 minute after extubation

coughing score

Timeframe: scores at the time point of 5 minutes after extubation