Agitated; State, Acute Reaction to Stress
Conditions
Keywords
dexmedetomidine, hydromophine, tonsillectomy and adenoidectomy
Brief 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.
Detailed description
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.
Interventions
DRUGDexmedetomidine 0.5μg／kg
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.
DRUGDexmedetomidine 1μg／kg
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.
Sponsors
Eye & ENT Hospital of Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 10 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| extubation time | duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins | the time of extubation after surgery |
| Agitation scores | scores at the time point of 0 minute after extubation | 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. |
| coughing score | scores at the time point of 0 minute after extubation | 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. |
Countries
China
Outcome results
None listed