Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
This study has been completed.
Sponsor:
University of Medicine and Dentistry New Jersey
Information provided by:
University of Medicine and Dentistry New Jersey
ClinicalTrials.gov Identifier:
NCT00468052
First received: April 27, 2007
Last updated: November 30, 2010
Last verified: November 2010
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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:
Drug Information available for:
Fentanyl
Fentanyl citrate
Dexmedetomidine
Dexmedetomidine hydrochloride
U.S. FDA Resources
Further study details as provided by University of Medicine and Dentistry 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
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 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 University of Medicine and Dentistry 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 May 21, 2013