Phase 3
N=137
Decrease Emergence Agitation and Provide Pain Relief for Children Undergoing Tonsillectomy & Adenoidectomy
Obstructive Sleep Apnea
Bottom Line
View on ClinicalTrials.gov: NCT00468052 ↗Enrolled (actual)
137
Serious AEs
0.8%
Results posted
Oct 2016
Primary outcome: Primary: Emergence Agitation and Pain — 14; 10; 4; 3 units on a scale — p=.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- dexmedetomidine (Drug); fentanyl (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- University of Medicine and Dentistry of New Jersey
- Primary completion
- May 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Emergence Agitation and Pain |
14; 10; 4; 3; 5; 3 | .001 sig |
| PRIMARY Duration of Agitation |
11.85; 6.59 | 0.004 sig |
| SECONDARY Hemodynamic Stability |
0; 0; 0; 0 | — |
| SECONDARY Time to Awaken |
8.75; 7.18 | 0.03 sig |
| SECONDARY Time to Extubation |
10.44; 8.59 | 0.02 sig |
| SECONDARY Number of Participants With SpO2 < or Equal to 95% |
2; 4 | — |
| SECONDARY Participants Requiring Morphine Rescue in PACU |
25; 11 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00468052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.