Not provided
Not provided
Not provided
Not provided
Not provided
The study was terminated due to slow accrual.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
St. Jude Children's Research Hospital is studying the best ways to prevent pain during and after procedures such as bone marrow aspiration and lumbar puncture with intrathecal (in the spinal fluid) chemotherapy. Researchers will study the effectiveness of combining anesthetics (medicines that help people sleep) and analgesics (medicines that relieve pain). Researchers believe that a combination of fentanyl (analgesic) and propofol (anesthetic), along with applying the skin-numbing-cream EMLA or L.M.X4â„¢ on the area where the procedure is performed, will provide better pain control.
Each patient enrolled on this study will have three different anesthetic combinations for three different procedures, in order to determine which combination worked best for each child.
The study focusses on the following primary aims:
The study focusses on the following secondary aims:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Fentanyl-1mcg/kg in 3 ml of Normal Saline |
|
| 2 | Active Comparator | Fentanyl - 0.5 mcg/kg in 3 ml normal saline |
|
| 3 | Placebo Comparator | normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain(Yes/No) | During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant's procedure. | 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. |
| Pain (Yes/No) | During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant's procedure. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 20% or Greater Change in Heart Rate | Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Doralina L. Anghelescu, M.D. | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
Not provided
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
Not provided
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.
A total of 168 participants were enrolled between March, 2002 and August, 2007.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| FG004 | 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. |
| FG005 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit One |
|
| ||||||||||||||||||
| Visit Two |
| |||||||||||||||||||
| Visit Three |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl 0.5/Placebo/Fentanyl 1 | |
| BG001 | Fentanyl 0.5/Fentanyl 1/Placebo | |
| BG002 | Placebo/Fentanyl 0.5/Fentanyl 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain(Yes/No) | During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant's procedure. | Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow. | Posted | Number | Participants | 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. |
|
Adverse events were assessed from the time of procedure up to 7 days post procedure
Four participants died during the study period.All 4 deaths were due to the primary disease or complications of the disease process.None of the deaths occurred within 7 days of that patient's procedure for which data was collected, and therefore is unrelated to the study treatment.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fentanyl 0.5mcg/kg | Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments. |
Not provided
Not provided
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Doralina Anghelescu, MD | St. Jude Children's Research Hospital | 866-278-5833 | referralinfo@stjude.org |
Not provided
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010636 | Phenols |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| EMLA | Drug | All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). EMLA application has to be over at least 60 minutes and not to exceed 5 hours. |
|
| L.M.X4 | Drug | All patients will have EMLA or LMX4 cream applied at the anticipated site of the bone marrow aspiration to ensure topical anesthesia, and will receive a total intravenous anesthetic technique (TIVA). In order to optimize transdermal anesthesia LMX4 application has to be over at least 30 minutes. |
|
| Propofol | Drug | Propofol - 1 mg/kg increments every 30 seconds-1minute until loss of consciousness is indicated by lack of response to verbal command and loss of eyelid reflex. |
|
| 20% or Greater Change in Respiratory Rate |
Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery. |
| 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. |
| 20% or Greater Change in Blood Pressure | Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery. | 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. |
| Movement | Movement (yes/no) measured during recovery after surgery. | 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. |
| Physician Decision |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| BG003 | Placebo/Fentanyl 1/Fentanyl 0.5 |
| BG004 | Fentanyl 1/Fentanyl 0.5/Placebo |
| BG005 | Fentanyl 1/Placebo/Fentanyl 0.5 |
| BG006 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | All 162 participants who enrolled and were randomized on the study are included in the baseline summary statistics. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | Fentanyl 1mcg/kg vs Placebo | Patients who completed treatment with Fentanyl 1 mcg/kg and placebo. |
| OG001 | Fentanyl 0.5mcg/kg vs Placebo | Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo. |
|
|
|
| Primary | Pain (Yes/No) | During the sedation recovery period, pain was measured by one of three validated pediatric scales. Scales were applied according to the developmental ability of the participant: Numerical Pain Scale, FACES pain scale, and FLACC pain scale (a score based on behaviors observed: face, legs, activity, cry, and consolability). All three scales are scored from 0 - 10 units on a scale, and are interchangeable for comparison purposes. Any score >0 was coded "pain", and score of 0 was coded "no pain", yielding one score for each participant's procedure. | Participants in this analysis are a subset of the 162 participants randomized since not all completed 3 visits on study. If a participant completed at least Visit 2 and received each of the 2 treatments compared they are included. Treatment on each visit was randomized; therefore these numbers cannot be derived directly from the participant flow. | Posted | Number | Participants | 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. |
|
|
|
|
| Secondary | 20% or Greater Change in Heart Rate | Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery. | Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo. | Posted | Number | Participants | 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. |
|
|
|
|
| Secondary | 20% or Greater Change in Respiratory Rate | Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery. | Due to study termination, not all Participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo. | Posted | Number | Participants | 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. |
|
|
|
|
| Secondary | 20% or Greater Change in Blood Pressure | Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery. | Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo. | Posted | Number | Participants | 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. |
|
|
|
|
| Secondary | Movement | Movement (yes/no) measured during recovery after surgery. | Due to study termination, not all participants completed three planned visits. 107 of the 162 participants enrolled on study received treatment with Fentanyl 0.5 mcg/kg. 104 of the 162 participants enrolled on study received treatment with Fentanyl 1mcg/kg. 105 of the 162 participants enrolled on study received treatment with Placebo. | Posted | Number | Participants | 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. |
|
|
|
|
| 0 |
| 107 |
| 0 |
| 107 |
| EG001 | Fentanyl 1mcg/kg | Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments. | 0 | 104 | 0 | 104 |
| EG002 | Placebo | Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments. | 0 | 105 | 0 | 105 |
Not provided
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| Title | Measurements |
|---|---|
|
| No-Pain on Fentanyl (1), No-Pain on Fentanyl (0.5) |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|