Phase 4
Completed N=49
Intranasal Fentanyl for Initial Treatment of a Vaso-occlusive Crisis
Anemia, Sickle Cell · Postoperative Pain
Source: ClinicalTrials.gov NCT01482091 ↗
Enrolled (actual)
49
Serious AEs
14.3%
Results posted
Aug 2016
Primary outcomePrimary: Change in Pain Score 20 Minutes After Administration of Study Drug — 1; 2 units on a scale — p=0.048
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine if intranasal fentanyl can decrease the pain of patients with sickle cell disease who present to the pediatric emergency department with a vaso-occlusive crisis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Score 20 Minutes After Administration of Study Drug |
1; 2 | 0.048 sig |
| SECONDARY Presence of Bradycardia |
0; 0 | — |
| SECONDARY Presence of Headache |
0; 4 | =0.05 |
| SECONDARY Admission Rate |
16; 13 | >0.05 |
| SECONDARY Length of Stay in ED |
— | — |
| SECONDARY Total Amount of Narcotics Administered |
— | — |
| SECONDARY Time to Study Drug Administration |
47; 43 | =0.68 |
| SECONDARY Change in Pain Score at 10 Minutes |
0; 2 | >0.05 |
| SECONDARY Change in Pain Score at 30 Minutes |
2; 2 | >0.05 |
| SECONDARY Change in Pain Score |
— | — |
| SECONDARY Respiratory Distress |
0; 0 | — |
| SECONDARY Hypotension |
2; 2 | — |
| SECONDARY Hypoxia |
0; 3 | >0.05 |
Eligibility Criteria
Inclusion Criteria
- Sickle Cell Disease
- Ages 3 years - 21 years
Exclusion Criteria for Enrollment:
- Pregnancy
- Known allergy to Fentanyl
- Usage of daily home opiates
Exclusion Criteria at presentation in ED with a painful crisis:
- Wong Baker FACES Pain Score 102°F
- Respiratory distress
- Priapism
- Isolated abdominal pain
- Isolated headache
- New neurological symptoms
- Severe rhinorrhea or epistaxis
- History of trauma
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT01482091). 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. Informational only — not medical advice.