Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
Completed · Phase 3
Conditions studied: Obstructive Sleep Apnea
In brief
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.
Key facts
- Study ID
- NCT00468052
- Run by
- University of Medicine and Dentistry of New Jersey
- People needed
- 122
- Starts
- 2007-03-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2016-12-05
Who can join
Age: 2 and older, up to 10. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ages 2-10 ASA rating of I-III undergoing general anesthesia tonsillectomy with and without adenoidectomy
You may not qualify if…
- 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
Where it is running
- UMDNJ University Hospital — Newark, New Jersey, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.