Trial Outcomes & Findings for Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries (NCT NCT02064894)
NCT ID: NCT02064894
Last Updated: 2017-08-03
Results Overview
Percentage of participants which pain intensity has decreased under 30 mm on the VAS at 60 minutes. The Visual Analogue Scale is a 0 to 100 mm continuous scale measuring the pain intensity. Score of 0="No Pain"; Score of 100="Worst imaginable pain"
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
501 participants
Primary outcome timeframe
60 minutes post-analgesia
Results posted on
2017-08-03
Participant Flow
Assessed for eligibility (n=5127) Excluded (n=4626) * Not meeting inclusion criteria (n=1670) * Excluded as per exclusion criteria (n=663) * Declined to participate (n=874) * Not evaluated (n=1144) * Other reasons (n=275) Randomized (n=501)
Participant milestones
| Measure |
Oral Morphine and Oral Ibuprofen
Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
|
Morphine and Placebo of Ibuprofen
Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
|
Ibuprofen and Placebo of Morphine
Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator
|
|---|---|---|---|
|
Overall Study
STARTED
|
99
|
201
|
201
|
|
Overall Study
Available at T-60
|
91
|
188
|
177
|
|
Overall Study
Avalaible at T-90
|
74
|
134
|
129
|
|
Overall Study
COMPLETED
|
56
|
99
|
86
|
|
Overall Study
NOT COMPLETED
|
43
|
102
|
115
|
Reasons for withdrawal
| Measure |
Oral Morphine and Oral Ibuprofen
Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
|
Morphine and Placebo of Ibuprofen
Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
|
Ibuprofen and Placebo of Morphine
Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
43
|
102
|
115
|
Baseline Characteristics
Oral Analgesic Utilization for CHildhood Musculoskeletal Injuries
Baseline characteristics by cohort
| Measure |
Oral Morphine and Oral Ibuprofen
n=91 Participants
Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
|
Morphine and Placebo of Ibuprofen
n=188 Participants
Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
|
Ibuprofen and Placebo of Morphine
n=177 Participants
Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator
|
Total
n=456 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.2 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
11.7 years
STANDARD_DEVIATION 2.7 • n=7 Participants
|
12.0 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
11.9 years
STANDARD_DEVIATION 2.7 • n=4 Participants
|
|
Age, Customized
6-11
|
39 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Age, Customized
12-17
|
52 Participants
n=5 Participants
|
103 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
258 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
204 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
252 Participants
n=4 Participants
|
|
VAS score at Baseline - Continuous
|
60.9 units on a scale
STANDARD_DEVIATION 15.5 • n=5 Participants
|
60.8 units on a scale
STANDARD_DEVIATION 15.8 • n=7 Participants
|
61.0 units on a scale
STANDARD_DEVIATION 17.1 • n=5 Participants
|
60.9 units on a scale
STANDARD_DEVIATION 16.2 • n=4 Participants
|
|
VAS score at Baseline stratified by pain intensity
30-69 mm
|
64 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
121 Participants
n=5 Participants
|
313 Participants
n=4 Participants
|
|
VAS score at Baseline stratified by pain intensity
> 69 mm
|
27 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
143 Participants
n=4 Participants
|
|
Injury type - n(%)
Fracture
|
43 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
175 Participants
n=4 Participants
|
|
Injury type - n(%)
Soft tissue injury
|
48 Participants
n=5 Participants
|
117 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
277 Participants
n=4 Participants
|
|
Injury type - n(%)
Missing
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Injury location - n(%)
Wrist
|
24 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
77 Participants
n=4 Participants
|
|
Injury location - n(%)
Ankle
|
21 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Injury location - n(%)
Knee
|
15 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Injury location - n(%)
Foot
|
6 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
|
Injury location - n(%)
Elbow
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Injury location - n(%)
Forearm
|
6 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Injury location - n(%)
Other
|
13 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
118 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 60 minutes post-analgesiaPercentage of participants which pain intensity has decreased under 30 mm on the VAS at 60 minutes. The Visual Analogue Scale is a 0 to 100 mm continuous scale measuring the pain intensity. Score of 0="No Pain"; Score of 100="Worst imaginable pain"
Outcome measures
| Measure |
Oral Morphine and Oral Ibuprofen
n=91 Participants
Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
|
Morphine and Placebo of Ibuprofen
n=188 Participants
Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
|
Ibuprofen and Placebo of Morphine
n=177 Participants
Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator
|
|---|---|---|---|
|
Pain Intensity - Percentage of Children Who Achieved VAS < 30 mm
|
33.0 Percentage of participants
Interval 24.2 to 43.1
|
29.3 Percentage of participants
Interval 23.2 to 36.1
|
29.9 Percentage of participants
Interval 23.7 to 37.1
|
SECONDARY outcome
Timeframe: 60, 90 and 120 minutesTo verify the occurence of any serious adverse event, such as respiratory depression or deep sedation, during all the time-periods of the study
Outcome measures
| Measure |
Oral Morphine and Oral Ibuprofen
n=91 Participants
Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
|
Morphine and Placebo of Ibuprofen
n=188 Participants
Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
|
Ibuprofen and Placebo of Morphine
n=177 Participants
Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator
|
|---|---|---|---|
|
Serious Adverse Event - Side Effects and Serious Adverse Events
Side effects
|
6 Participants
|
39 Participants
|
38 Participants
|
|
Serious Adverse Event - Side Effects and Serious Adverse Events
Serious adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Oral Morphine and Oral Ibuprofen
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Morphine and Placebo of Ibuprofen
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Ibuprofen and Placebo of Morphine
Serious events: 0 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Oral Morphine and Oral Ibuprofen
n=91 participants at risk
Oral morphine (syrup) 0.2mg/kg (max. 15 mg) and oral ibuprofen (syrup) 10mg/kg (max. 600 mg) both administered once during the 2 hour-study time frame
oral morphine and oral ibuprofen: The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
|
Morphine and Placebo of Ibuprofen
n=188 participants at risk
Oral morphine 0.2mg/kg (max. 15 mg) and a placebo of ibuprofen both administered once during the 2-hour time frame of the study
Oral morphine: Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
|
Ibuprofen and Placebo of Morphine
n=177 participants at risk
Ibuprofen 10mg/kg (max. 600 mg) and placebo of morphine both administered once during the 2-hour time frame of the study
Oral ibuprofen: oral ibuprofen combine to a placebo is the active comparator
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/91
|
5.9%
11/188
|
4.0%
7/177
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/91
|
3.7%
7/188
|
4.0%
7/177
|
|
Nervous system disorders
Drowsiness
|
0.00%
0/91
|
2.7%
5/188
|
2.3%
4/177
|
|
General disorders
Fatigue
|
2.2%
2/91
|
2.1%
4/188
|
2.3%
4/177
|
|
Nervous system disorders
Headache
|
2.2%
2/91
|
2.1%
4/188
|
2.3%
4/177
|
|
General disorders
Others
|
2.2%
2/91
|
4.3%
8/188
|
6.8%
12/177
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place