Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy

This study has been completed.
Sponsor:
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00468052
First received: April 27, 2007
Last updated: November 30, 2010
Last verified: November 2010
  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:
  • vital signs (Heart rate, blood pressure, oxygen sat,respiratory rate, end title carbon dioxide, BIS)at five minute intervals perioperatively [ Time Frame: 5 minute intervals postoperatively ] [ Designated as safety issue: Yes ]
  • time to awakening [ Time Frame: following end of anesthetic medication ] [ Designated as safety issue: Yes ]
  • time to extubation [ Time Frame: after awakening ] [ Designated as safety issue: Yes ]
  • Pain and emergent agitation tool [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective Pain Scale and use of rescue medication [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Pediatric Anesthesia Emergence Delirium [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: Yes ]
  • Post operative Emesis [ Time Frame: 2 hours postoperatively ] [ Designated as safety issue: Yes ]

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 Drug: fentanyl
1 microgram/kilogram as a bolus
Other Name: Sublimaze
Experimental: dexmedetomidine 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
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: Anuradha Patel, MD, UMDNJ
ClinicalTrials.gov Identifier: NCT00468052     History of Changes
Other Study ID Numbers: 0120060313
Study First Received: April 27, 2007
Last Updated: November 30, 2010
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:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Fentanyl
Dexmedetomidine
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Analgesics, Opioid
Hypnotics and Sedatives
Analgesics, Non-Narcotic
Adrenergic alpha-2 Receptor Agonists

ClinicalTrials.gov processed this record on July 28, 2014