Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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The computer generates random numbers to allocate patients into different group. Trained research staff who are not involved in the study collect the data. The observer who only stayed in PACU was blinded to the allocation and responsible to record the data. The primary measurement are pain scores, PAED scores, coughing was evaluated on a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm), and extubation time. The secondary measurements are the time to discharge from the post-anaesthesia care unit, and the number of postoperative desaturation. A sample size of 57 was determined by analysis based on the assumption of the decline of extubation time from other similar study and α=0.05,β=0.2. The continuous variables were presented as means ± SD and the categorical variables were expressed as frequency. The outcome of interest is extubation time decline.

Official Title
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The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy

Conditions
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Agitated; State, Acute Reaction to Stress

Intervention / Treatment
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* Drug: Dexmedetomidine 0.5μg／kg
* Drug: Dexmedetomidine 1μg／kg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia | Drug: Dexmedetomidine 0.5μg／kg<br>* Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.<br>* Other names: Dexmedetomidine Hydrochloride Injection;|
| Experimental: group B<br>Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia | Drug: Dexmedetomidine 1μg／kg<br>* Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.<br>* Other names: Dexmedetomidine Hydrochloride Injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| extubation time | the time of extubation after surgery | duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins | 
| Agitation scores | pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable. Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation. | scores at the time point of 0 minute after extubation | 
| Agitation scores | pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable. Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation. | scores at the time point of 5 minutes after extubation | 
| Agitation scores | pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable. Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation. | scores at the time point of 10 minutes after extubation | 
| Agitation scores | pediatric anesthesia emergence delirium (PAED) scores included five behaviors:(1)makes eye contact with caregiver,(2) actions are purposeful,(3) aware of surroundings,(4) restless,(5) inconsolable. Each behavior was correlated to different degree(4= not at all,3= just a little, 2= quite a bit, 1= very much,0= extremely). The scores for each of the five listed behaviors are added to achieve a total score (maximum score of 20, minimum score of 0). A score of >12 is diagnosed to agitation. | scores at the time point of 15 minutes after extubation | 
| coughing score | a 4-point scale that is used to measure severity of coughing(maximum score of 4, minimum score of 1):1= no coughing,2=minimal coughing, one or two times,3= moderate coughing,3-4 times,4= severe coughing, more than 5 times. | scores at the time point of 0 minute after extubation | 
| coughing score | a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm). | scores at the time point of 5 minutes after extubation | 
| coughing score | a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm). | scores at the time point of 10 minutes after extubation | 
| coughing score | a 9-point scale (1= no coughing, 2= minimal coughing, one or two times, 3-4= moderate coughing, 3-4 times, 5-6= moderate coughing, more than 5 times, 7-8= severe coughing, more than 10 times, 9= laryngospasm) | scores at the time point of 15 minutes after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dexmedetomidine, hydromophine, tonsillectomy and adenoidectomy