Dexmedetomidine Combined With Hydromorphone in Tonsillectomy and Adenoidectomy

NCT03760809 | Completed Phase 4

• 1 other identifier: dex-hyd
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Agitated; State, Acute Reaction to Stress

Keywords

dexmedetomidine; hydromophine; tonsillectomy and adenoidectomy

Outcome Measures

Primary Outcomes (9)

• 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

Study Arms (2)

group A

EXPERIMENTAL

Dexmedetomidine(0.5 μg／kg)/hydromophine-based general anesthesia

Drug: Dexmedetomidine 0.5μg／kg

group B

EXPERIMENTAL

Dexmedetomidine(1μg／kg)/hydromophine-based general anesthesia

Drug: Dexmedetomidine 1μg／kg

Interventions

Dexmedetomidine 0.5μg／kg DRUG

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.

Also known as: Dexmedetomidine Hydrochloride Injection

group A

Dexmedetomidine 1μg／kg DRUG

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.

Also known as: Dexmedetomidine Hydrochloride Injection

group B

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• experienced tonsillectomy and adenoidectomy
• ASA physical status I-II
• weight 12-30 kg

You may not qualify if:

• respiratory disease
• circulatory or nervous system disease
• hepatic dysfunction
• known adverse reactions to hydromophine and dexmedetomidine

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

Study Sites (1)

Anesthesiology Department of Affiliated Eye and ENT Hospital, Fudan University

Shanghai, Shanghai Municipality, 200031, China

Location

Related Publications (5)

• 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.

  PMID: 20610555 BACKGROUND

• 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.

  PMID: 11442853 RESULT

• 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.

  PMID: 20705788 RESULT

• 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.

  PMID: 26332857 RESULT

• 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.

  PMID: 34627829 DERIVED

MeSH Terms

Conditions

Psychomotor Agitation; Stress Disorders, Traumatic, Acute

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• e ji Jia, M.D.

  Eye and ENT Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 30, 2018
• Study Start: January 4, 2019
• Primary Completion: February 10, 2019
• Study Completion: April 1, 2019
• Last Updated: June 22, 2021

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)