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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00468052
Recruitment Status : Completed
First Posted : May 1, 2007
Results First Posted : October 11, 2016
Last Update Posted : December 5, 2016
Information provided by (Responsible Party):
Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey )

Brief Summary:
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 or disease Intervention/treatment Phase
Obstructive Sleep Apnea Drug: dexmedetomidine Drug: fentanyl Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Use of Dexmedetomidine Infusion for Analgesia and Emergence Agitation for Children Undergoing Tonsillectomy and Adenotonsillectomy
Study Start Date : March 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: fentanyl
fentanyl bolus
Drug: fentanyl
1 microgram/kilogram as a bolus
Other Name: Sublimaze
Experimental: dexmedetomidine
dexmedetomidine over 10 min followed by
Drug: dexmedetomidine
2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion
Other Name: Precedex

Primary Outcome Measures :
  1. Emergence Agitation and Pain [ Time Frame: On arrival to PACU and 2 hours postoperatively ]

    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

  2. Duration of Agitation [ Time Frame: on arrival to PACU and for 2 hours postoperatively ]
    Cole EA scale 1=calm , 5=unconsolable

Secondary Outcome Measures :
  1. Hemodynamic Stability [ Time Frame: intraoperatively ]
    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.

  2. Time to Awaken [ Time Frame: at end of surgery ]
    defined as spontaneous eye opening or on command

  3. Time to Extubation [ Time Frame: at end of surgical procedure ]
    defined as time from end of surgery to tracheal extubation

  4. Number of Participants With SpO2 < or Equal to 95% [ Time Frame: on arrival to PACU and 2 hours postoperatively ]
  5. Participants Requiring Morphine Rescue in PACU [ Time Frame: arrival in PACU to 2 hours postoperatively ]

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00468052

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

Responsible Party: University of Medicine and Dentistry of New Jersey Identifier: NCT00468052     History of Changes
Other Study ID Numbers: 0120060313
First Posted: May 1, 2007    Key Record Dates
Results First Posted: October 11, 2016
Last Update Posted: December 5, 2016
Last Verified: September 2015

Keywords provided by Rutgers, The State University of New Jersey ( University of Medicine and Dentistry of New Jersey ):
obstructive sleep apnea

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Emergence Delirium
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurologic Manifestations
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists