An interventional study of Fentanyl and placebo in Pain Uterus, sponsored by University of Hawaii. Completed at 2 sites in United States. Open to female participants aged 14 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-13.
Sponsored by University of Hawaii · Not applicable, Interventional, and Treatment
Intranasal fentanyl has been found to be safe and effective in the reduction of pain among pediatric and adult populations. The investigators hypothesize that patients who receive 100 mcg of intranasal fentanyl for pain control before first-trimester uterine aspiration will report lower pain scores than those who receive placebo. The investigators will test this hypothesis using a randomized, double-blind, placebo-controlled trial comparing pain reported during uterine aspiration between patients who receive either intranasal fentanyl or intranasal saline prior to the procedure.
University of Hawaii is the lead sponsor of 95 studies on the registry; 20 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Fentanyl
Drug: placebo
100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start
1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start
Pain during uterine aspiration
Self reported on 100 mm VAS
Time frame: During uterine aspiration or immediately after uterine aspiration
Patient satisfaction with procedural pain control
Self reported on 100 mm VAS
Time frame: approximately 15 minutes after procedure ends
Post-procedural pain
Self reported on 100 mm VAS
Time frame: approximately 15 minutes after procedure end
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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University of Hawaii