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| Study Type: | Interventional |
|---|---|
| Study Design: | Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
| Conditions: |
Bone Marrow Disease Pain |
| Interventions: |
Drug: Fentanyl Drug: EMLA Drug: L.M.X4 Drug: Propofol |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| A total of 168 participants were enrolled between March, 2002 and August, 2007. |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| 168 participants were enrolled and were expected to receive 3 Bone Marrow Aspirations/Lumbar Puncture Intrathecal Chemotherapy procedures; 6 patients withdrew (eg: medical withdrawal, withdrawal of consent and other). 162 were randomized, of which 77 completed all 3 treatments. |
| Description | |
|---|---|
| Fentanyl 0.5 / Placebo / Fentanyl 1 | Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit. |
| Fentanyl 0.5 /Fentanyl 1 / Placebo | Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit. |
| Placebo / Fentanyl 0.5 /Fentanyl 1 | Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit. |
| Placebo /Fentanyl 1 / Fentanyl 0.5 | Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit. |
| Fentanyl 1 / Fentanyl 0.5 / Placebo | Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit. |
| Fentanyl 1 / Placebo /Fentanyl 0.5 | Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit. |
| Fentanyl 0.5 / Placebo / Fentanyl 1 | Fentanyl 0.5 /Fentanyl 1 / Placebo | Placebo / Fentanyl 0.5 /Fentanyl 1 | Placebo /Fentanyl 1 / Fentanyl 0.5 | Fentanyl 1 / Fentanyl 0.5 / Placebo | Fentanyl 1 / Placebo /Fentanyl 0.5 | |
|---|---|---|---|---|---|---|
| STARTED | 30 | 28 | 25 | 26 | 25 | 28 |
| COMPLETED | 26 | 27 | 25 | 26 | 25 | 26 |
| NOT COMPLETED | 4 | 1 | 0 | 0 | 0 | 2 |
| Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 |
| Physician Decision | 3 | 1 | 0 | 0 | 0 | 1 |
| Study Discontinued | 0 | 0 | 0 | 0 | 0 | 0 |
| Death | 0 | 0 | 0 | 0 | 0 | 0 |
| Fentanyl 0.5 / Placebo / Fentanyl 1 | Fentanyl 0.5 /Fentanyl 1 / Placebo | Placebo / Fentanyl 0.5 /Fentanyl 1 | Placebo /Fentanyl 1 / Fentanyl 0.5 | Fentanyl 1 / Fentanyl 0.5 / Placebo | Fentanyl 1 / Placebo /Fentanyl 0.5 | |
|---|---|---|---|---|---|---|
| STARTED | 26 | 27 | 25 | 26 | 25 | 26 |
| COMPLETED | 21 | 24 | 23 | 18 | 19 | 18 |
| NOT COMPLETED | 5 | 3 | 2 | 8 | 6 | 8 |
| Death | 0 | 0 | 0 | 1 | 0 | 1 |
| Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal by Subject | 1 | 1 | 1 | 0 | 1 | 1 |
| Study Discontinued | 3 | 2 | 1 | 7 | 5 | 6 |
| Fentanyl 0.5 / Placebo / Fentanyl 1 | Fentanyl 0.5 /Fentanyl 1 / Placebo | Placebo / Fentanyl 0.5 /Fentanyl 1 | Placebo /Fentanyl 1 / Fentanyl 0.5 | Fentanyl 1 / Fentanyl 0.5 / Placebo | Fentanyl 1 / Placebo /Fentanyl 0.5 | |
|---|---|---|---|---|---|---|
| STARTED | 21 | 24 | 23 | 18 | 19 | 18 |
| COMPLETED | 14 | 17 | 14 | 9 | 11 | 12 |
| NOT COMPLETED | 7 | 7 | 9 | 9 | 8 | 6 |
| Death | 0 | 0 | 1 | 0 | 1 | 0 |
| Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 |
| Withdrawal by Subject | 0 | 1 | 1 | 2 | 0 | 0 |
| Study Discontinued | 7 | 6 | 7 | 7 | 7 | 6 |
Baseline Characteristics
| Description | |
|---|---|
| Fentanyl 0.5/Placebo/Fentanyl 1 | No text entered. |
| Fentanyl 0.5/Fentanyl 1/Placebo | No text entered. |
| Placebo/Fentanyl 0.5/Fentanyl 1 | No text entered. |
| Placebo/Fentanyl 1/Fentanyl 0.5 | No text entered. |
| Fentanyl 1/Fentanyl 0.5/Placebo | No text entered. |
| Fentanyl 1/Placebo/Fentanyl 0.5 | No text entered. |
| Fentanyl 0.5/Placebo/Fentanyl 1 | Fentanyl 0.5/Fentanyl 1/Placebo | Placebo/Fentanyl 0.5/Fentanyl 1 | Placebo/Fentanyl 1/Fentanyl 0.5 | Fentanyl 1/Fentanyl 0.5/Placebo | Fentanyl 1/Placebo/Fentanyl 0.5 | Total | |
|---|---|---|---|---|---|---|---|
|
Number of Participants
[units: participants] |
30 | 28 | 25 | 26 | 25 | 28 | 162 |
|
Age
[1] [units: years] Mean ± Standard Deviation |
6.4 ± 4.3 | 7.2 ± 4.5 | 7.6 ± 4.8 | 7.1 ± 4.1 | 7.3 ± 4.7 | 7.1 ± 4.4 | 7.1 ± 4.4 |
|
Gender
[1] [units: participants] |
|||||||
| Female | 15 | 11 | 12 | 10 | 9 | 13 | 70 |
| Male | 15 | 17 | 13 | 16 | 16 | 15 | 92 |
| [1] | All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics. |
|---|
Outcome Measures
| 1. Primary: | Pain(Yes/No) [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] |
| 2. Primary: | Pain (Yes/No) [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] |
| 3. Secondary: | 20% or Greater Change in Heart Rate [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] |
| 4. Secondary: | 20% or Greater Change in Respiratory Rate [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] |
| 5. Secondary: | 20% or Greater Change in Blood Pressure [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] |
| 6. Secondary: | Movement [ Time Frame: The participant was monitored from the end of the procedure until sedation recovery, which lasted a maximum of 65 min. Discharge from the recovery area was determined by hospital standards of care. ] |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| All 162 participants were expected to receive three treatments. Not all participants received all three treatments. Therefore, analysis required the identification of subsets of treated participants. The trial terminated early due to slow accrual. |
| Responsible Party: | Doralina L. Anghelescu, MD / Principal Investigator, St. Jude Children's Research Hospital |
| ClinicalTrials.gov Identifier: | NCT00187135 History of Changes |
| Other Study ID Numbers: | PFE |
| Study First Received: | September 12, 2005 |
| Results First Received: | October 13, 2009 |
| Last Updated: | April 22, 2010 |
| Health Authority: | United States: Institutional Review Board |
