Trial Outcomes & Findings for Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration (NCT NCT00187135)
NCT ID: NCT00187135
Last Updated: 2017-04-04
Results Overview
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.
TERMINATED
PHASE3
168 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.
2017-04-04
Participant Flow
A total of 168 participants were enrolled between March, 2002 and August, 2007.
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.
Participant milestones
| Measure |
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.
|
|---|---|---|---|---|---|---|
|
Visit One
STARTED
|
30
|
28
|
25
|
26
|
25
|
28
|
|
Visit One
COMPLETED
|
26
|
27
|
25
|
26
|
25
|
26
|
|
Visit One
NOT COMPLETED
|
4
|
1
|
0
|
0
|
0
|
2
|
|
Visit Two
STARTED
|
26
|
27
|
25
|
26
|
25
|
26
|
|
Visit Two
COMPLETED
|
21
|
24
|
23
|
18
|
19
|
18
|
|
Visit Two
NOT COMPLETED
|
5
|
3
|
2
|
8
|
6
|
8
|
|
Visit Three
STARTED
|
21
|
24
|
23
|
18
|
19
|
18
|
|
Visit Three
COMPLETED
|
14
|
17
|
14
|
9
|
11
|
12
|
|
Visit Three
NOT COMPLETED
|
7
|
7
|
9
|
9
|
8
|
6
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|---|---|---|---|
|
Visit One
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
|
Visit One
Physician Decision
|
3
|
1
|
0
|
0
|
0
|
1
|
|
Visit Two
Death
|
0
|
0
|
0
|
1
|
0
|
1
|
|
Visit Two
Physician Decision
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Visit Two
Withdrawal by Subject
|
1
|
1
|
1
|
0
|
1
|
1
|
|
Visit Two
Study Discontinued
|
3
|
2
|
1
|
7
|
5
|
6
|
|
Visit Three
Death
|
0
|
0
|
1
|
0
|
1
|
0
|
|
Visit Three
Withdrawal by Subject
|
0
|
1
|
1
|
2
|
0
|
0
|
|
Visit Three
Study Discontinued
|
7
|
6
|
7
|
7
|
7
|
6
|
Baseline Characteristics
Study of Fentanyl-Propofol-EMLA of L.M.X4 Technique for Bone Marrow Aspiration
Baseline characteristics by cohort
| Measure |
Fentanyl 0.5/Placebo/Fentanyl 1
n=30 Participants
|
Fentanyl 0.5/Fentanyl 1/Placebo
n=28 Participants
|
Placebo/Fentanyl 0.5/Fentanyl 1
n=25 Participants
|
Placebo/Fentanyl 1/Fentanyl 0.5
n=26 Participants
|
Fentanyl 1/Fentanyl 0.5/Placebo
n=25 Participants
|
Fentanyl 1/Placebo/Fentanyl 0.5
n=28 Participants
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
6.4 years
STANDARD_DEVIATION 4.3 • n=99 Participants
|
7.2 years
STANDARD_DEVIATION 4.5 • n=107 Participants
|
7.6 years
STANDARD_DEVIATION 4.8 • n=206 Participants
|
7.1 years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
7.3 years
STANDARD_DEVIATION 4.7 • n=31 Participants
|
7.1 years
STANDARD_DEVIATION 4.4 • n=30 Participants
|
7.1 years
STANDARD_DEVIATION 4.4 • n=3 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
13 Participants
n=30 Participants
|
70 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
92 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Fentanyl 1mcg/kg vs Placebo
n=71 Participants
Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
|
Fentanyl 0.5mcg/kg vs Placebo
n=79 Participants
Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
|
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.
|
|---|---|---|---|
|
Pain(Yes/No)
Pain with Fentanyl and pain with Placebo
|
0 Participants
|
6 Participants
|
—
|
|
Pain(Yes/No)
Pain with Fentanyl and no-pain with Placebo
|
7 Participants
|
8 Participants
|
—
|
|
Pain(Yes/No)
No-pain with Fentanyl pain with Placebo
|
10 Participants
|
5 Participants
|
—
|
|
Pain(Yes/No)
No-pain with Fentanyl no-pain with Placebo
|
54 Participants
|
60 Participants
|
—
|
PRIMARY outcome
Timeframe: 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.Population: 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.
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.
Outcome measures
| Measure |
Fentanyl 1mcg/kg vs Placebo
n=74 Participants
Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
|
Fentanyl 0.5mcg/kg vs Placebo
Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
|
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.
|
|---|---|---|---|
|
Pain (Yes/No)
Pain on Fentanyl (1), Pain on Fentanyl (0.5)
|
2 Participants
|
—
|
—
|
|
Pain (Yes/No)
Pain on Fentanyl (1) No-pain on Fentanyl (0.5)
|
3 Participants
|
—
|
—
|
|
Pain (Yes/No)
No-Pain on Fentanyl (1), Pain on Fentanyl (0.5)
|
5 Participants
|
—
|
—
|
|
Pain (Yes/No)
No-Pain on Fentanyl (1), No-Pain on Fentanyl (0.5)
|
64 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Measurements of 20% change in Heart Rate (yes/no) taken during recovery after surgery.
Outcome measures
| Measure |
Fentanyl 1mcg/kg vs Placebo
n=107 Participants
Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
|
Fentanyl 0.5mcg/kg vs Placebo
n=104 Participants
Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
|
Placebo
n=105 Participants
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.
|
|---|---|---|---|
|
20% or Greater Change in Heart Rate
Yes
|
7 Participants
|
6 Participants
|
8 Participants
|
|
20% or Greater Change in Heart Rate
No
|
100 Participants
|
98 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Measurements of 20% change in respiratory rate(yes/no) taken during recovery after surgery.
Outcome measures
| Measure |
Fentanyl 1mcg/kg vs Placebo
n=107 Participants
Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
|
Fentanyl 0.5mcg/kg vs Placebo
n=104 Participants
Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
|
Placebo
n=105 Participants
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.
|
|---|---|---|---|
|
20% or Greater Change in Respiratory Rate
Yes
|
21 Participants
|
20 Participants
|
24 Participants
|
|
20% or Greater Change in Respiratory Rate
No
|
86 Participants
|
84 Participants
|
81 Participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Measurements of 20% change in blood pressure(yes/no) taken during recovery after surgery.
Outcome measures
| Measure |
Fentanyl 1mcg/kg vs Placebo
n=107 Participants
Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
|
Fentanyl 0.5mcg/kg vs Placebo
n=104 Participants
Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
|
Placebo
n=105 Participants
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.
|
|---|---|---|---|
|
20% or Greater Change in Blood Pressure
Yes
|
12 Participants
|
10 Participants
|
14 Participants
|
|
20% or Greater Change in Blood Pressure
No
|
95 Participants
|
94 Participants
|
91 Participants
|
SECONDARY outcome
Timeframe: 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.Population: 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.
Movement (yes/no) measured during recovery after surgery.
Outcome measures
| Measure |
Fentanyl 1mcg/kg vs Placebo
n=107 Participants
Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
|
Fentanyl 0.5mcg/kg vs Placebo
n=104 Participants
Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
|
Placebo
n=105 Participants
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.
|
|---|---|---|---|
|
Movement
Yes
|
57 Participants
|
45 Participants
|
58 Participants
|
|
Movement
No
|
50 Participants
|
59 Participants
|
47 Participants
|
Adverse Events
Fentanyl 0.5mcg/kg
Fentanyl 1mcg/kg
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Doralina Anghelescu, MD
St. Jude Children's Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place