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Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )
ClinicalTrials.gov Identifier:
NCT00468052
First received: April 27, 2007
Last updated: August 17, 2016
Last verified: September 2015
  Purpose
Pediatric tonsillectomy (with or without adenoidectomy) is a brief but painful surgery carried out in children who very often also present with obstructive sleep apnea. To provide pain relief, i.e. analgesia, current practice relies on opioids , e.g., morphine or fentanyl. These narcotics are known to depress respiration and to increase the incidence of post-operative nausea and vomiting. These side effects are worrisome in this patient cohort. An alternative medication, dexmedetomidine, may have an opiate sparing effect and has a high safety profile in adults as well as in sedation in children. The purpose of this study is to determine if intravenous dexmedetomidine given as an infusion during general anesthesia for tonsillectomy or adenotonsillectomy reduces the incidence and severity of emergence agitation, improves analgesia and reduces nausea and vomiting in the 60 minutes following surgery.

Condition Intervention Phase
Obstructive Sleep Apnea
Drug: dexmedetomidine
Drug: fentanyl
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Use of Dexmedetomidine Infusion for Analgesia and Emergence Agitation for Children Undergoing Tonsillectomy and Adenotonsillectomy

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Emergence Agitation and Pain [ Time Frame: On arrival to PACU and 2 hours postoperatively ] [ Designated as safety issue: No ]

    emergence agitation and pain will be assessed. Pediatric Anesthesia Emergence Delirium Scale (PAED) range 0-20 a lower score indicates the child is calm and the higher score indicates severe agitation. Cole Agitation Scale was employed which is a 5 point Likert scale. Parameters ranging 1 to 5 1=child is calm and 5 =the child is severly agitated .

    Objective Pain Score range is 0-10 (higher score the greater pain). 3 Parameters are captured systolic b/p,crying, movements, agitation , complaints of pain


  • Duration of Agitation [ Time Frame: on arrival to PACU and for 2 hours postoperatively ] [ Designated as safety issue: No ]
    Cole EA scale 1=calm , 5=unconsolable


Secondary Outcome Measures:
  • Hemodynamic Stability [ Time Frame: intraoperatively ] [ Designated as safety issue: Yes ]
    Participants whose heart rate per minute was below 60 intraoperatively. Participants whose systolic blood pressure dremonstrated < 30% decrease from baseline and sustained for 5 minutes received rescue as defined by the protocol.

  • Time to Awaken [ Time Frame: at end of surgery ] [ Designated as safety issue: Yes ]
    defined as spontaneous eye opening or on command

  • Time to Extubation [ Time Frame: at end of surgical procedure ] [ Designated as safety issue: No ]
    defined as time from end of surgery to tracheal extubation


Enrollment: 122
Study Start Date: March 2007
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: fentanyl
fentanyl bolus 1ug.kg-1
Drug: fentanyl
1 microgram/kilogram as a bolus
Other Name: Sublimaze
Experimental: dexmedetomidine
dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1
Drug: dexmedetomidine
2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion
Other Name: Precedex

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 10 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy

Exclusion Criteria:

  • diagnosis of anxiety disorder or chronic pain syndrome chronic disabilities or developmental delays are currently on psychotherapeutic or sedating medication are on chronic pain medication or opiate any known adverse effect to the study drug any known cardiac abnormalities
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00468052

Locations
United States, New Jersey
UMDNJ University Hospital
Newark, New Jersey, United States, 07103
Sponsors and Collaborators
University of Medicine and Dentistry of New Jersey
Investigators
Principal Investigator: Anuradha Patel, MD University of Medicne & Dentistry of New Jersey
  More Information

Publications:
Responsible Party: University of Medicine and Dentistry of New Jersey
ClinicalTrials.gov Identifier: NCT00468052     History of Changes
Other Study ID Numbers: 0120060313 
Study First Received: April 27, 2007
Results First Received: September 13, 2013
Last Updated: August 17, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Rutgers, The State University of New Jersey:
obstructive sleep apnea
tonsillectomy
adenoidectomy

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Fentanyl
Dexmedetomidine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on December 02, 2016