Phase 4
N=116
An Open-label Study of Hydromorphone Oral Solution in Subjects Aged 28 Days to 16 Years for Postoperative Pain
Postoperative Pain
Bottom Line
View on ClinicalTrials.gov: NCT00465647 ↗Enrolled (actual)
116
Serious AEs
4.3%
Results posted
Mar 2011
Primary outcome: Primary: Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl) — 114 L/hour
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Hydromorphone (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Purdue Pharma LP
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl) |
114 | — |
| SECONDARY Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] |
1.34; 2.67; 2.71; 1.13; 1.07; 2.17 | — |
| SECONDARY Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time |
1.50; 2.59; 1.20; 2.25; 1.33; 0.92 | — |
| SECONDARY Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time |
4.04; 3.73; 3.95; 4.09; 4.13; 4.19 | — |
Summary
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
Eligibility Criteria
Inclusion Criteria
- Pediatric subjects aged 28 days to 16 years,
- Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours),
- Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Exclusion Criteria
- Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve,
- Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone,
- Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone.
Other protocol-specific inclusion/exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT00465647). 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.