Clinical trial NCT03760809: Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy
Official title: The Effect of Different Dose of Dexmedetomidine Combined With Hydromorphone in Children With Tonsillectomy and Adenoidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Agitated; State, Acute Reaction to Stress
Keywords: dexmedetomidine
hydromophine
tonsillectomy and adenoidectomy
Lead sponsor: Eye & ENT Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 130
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: extubation time
timeFrame: duration from the time that patients arrived in PACU to the time of extubation, though study completion, average 40 mins
measure: Agitation scores
timeFrame: scores at the time point of 0 minute after extubation
measure: Agitation scores
timeFrame: scores at the time point of 5 minutes after extubation
measure: Agitation scores
timeFrame: scores at the time point of 10 minutes after extubation
measure: Agitation scores
timeFrame: scores at the time point of 15 minutes after extubation
measure: coughing score
timeFrame: scores at the time point of 0 minute after extubation
measure: coughing score
timeFrame: scores at the time point of 5 minutes after extubation
measure: coughing score
timeFrame: scores at the time point of 10 minutes after extubation
measure: coughing score
timeFrame: scores at the time point of 15 minutes after extubation
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Eye and ENT Hospital of Fudan University
name: e ji Jia, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olutoye OA, Glover CD, Diefenderfer JW, McGilberry M, Wyatt MM, Larrier DR, Friedman EM, Watcha MF. The effect of intraoperative dexmedetomidine on postoperative analgesia and sedation in pediatric patients undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Aug;111(2):490-5. doi: 10.1213/ANE.0b013e3181e33429. Epub 2010 Jul 7.
citation: Brown KA. What we don't know about childhood obstructive sleep apnoea. Paediatr Anaesth. 2001 Jul;11(4):385-9. doi: 10.1046/j.1460-9592.2001.00719.x. No abstract available.
citation: Patel A, Davidson M, Tran MC, Quraishi H, Schoenberg C, Sant M, Lin A, Sun X. Dexmedetomidine infusion for analgesia and prevention of emergence agitation in children with obstructive sleep apnea syndrome undergoing tonsillectomy and adenoidectomy. Anesth Analg. 2010 Oct;111(4):1004-10. doi: 10.1213/ANE.0b013e3181ee82fa. Epub 2010 Aug 12.
citation: Hauber JA, Davis PJ, Bendel LP, Martyn SV, McCarthy DL, Evans MC, Cladis FP, Cunningham S, Lang RS, Campbell NF, Tuchman JB, Young MC. Dexmedetomidine as a Rapid Bolus for Treatment and Prophylactic Prevention of Emergence Agitation in Anesthetized Children. Anesth Analg. 2015 Nov;121(5):1308-15. doi: 10.1213/ANE.0000000000000931.
citation: Yi W, Li J, Zhuang Y, Wan L, Li W, Jia J. The effect of two different doses of dexmedetomidine to prevent emergence agitation in children undergoing adenotonsillectomy: a randomized controlled trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):63-68. doi: 10.1016/j.bjane.2021.08.019. Epub 2021 Oct 8.