Trial Outcomes & Findings for A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy (NCT NCT01267136)
NCT ID: NCT01267136
Last Updated: 2014-04-17
Results Overview
Average number of post-operative days with pain score \>4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
84 participants
Primary outcome timeframe
Efficacy was assessed daily during the 10-day postoperative recovery period.
Results posted on
2014-04-17
Participant Flow
The study was introduced to 137 potential subjects during or following an outpatient office evaluation with an ear/nose/throat (ENT) surgeon between February 2011 and May 2012.
The study was introduced to 137 potential subjects, and 84 children were enrolled in the study and assigned to one of the two study arms.
Participant milestones
| Measure |
Capital® With Codeine Suspension
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
|
Tramadol Suspension
Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
COMPLETED
|
38
|
36
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Comparison of Postoperative Tramadol Versus Acetaminophen With Codeine in Children Undergoing Tonsillectomy
Baseline characteristics by cohort
| Measure |
Capital® With Codeine Suspension
n=42 Participants
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
|
Tramadol Suspension
n=42 Participants
Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
42 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
6.4 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
6.6 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
6.5 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Efficacy was assessed daily during the 10-day postoperative recovery period.Average number of post-operative days with pain score \>4/10. Pain score assessments were administered once daily by parents using either the Numeric Rating Scale (NRS-11) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 8-15 (von Baeyer et al., 2009) or the Faces Pain Scale-Revised (FPS-R) (with anchors 0=no pain and 10=highest pain imaginable) for children ages 4-10 (Hicks et al., 2001).
Outcome measures
| Measure |
Capital® With Codeine Suspension
n=38 Participants
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
|
Tramadol Suspension
n=36 Participants
Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
|
|---|---|---|
|
Efficacy of Two Different Liquid Pain Medications: Tramadol vs. Codeine/Acetaminophen During the Post-tonsillectomy Recovery Period.
|
1.5 days
Interval 0.0 to 9.0
|
1 days
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: Side effects will be observed and recorded daily by caregivers for a total of 10 days in the take-home diary.Parent-reported side effects entered in 10-day diary.
Outcome measures
| Measure |
Capital® With Codeine Suspension
n=38 Participants
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
|
Tramadol Suspension
n=36 Participants
Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
|
|---|---|---|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Nausea
|
20 participants
|
20 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Vomiting
|
21 participants
|
18 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Fever
|
11 participants
|
10 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Itching
|
5 participants
|
12 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Rash
|
1 participants
|
1 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Sweating
|
9 participants
|
7 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Dizziness
|
15 participants
|
17 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Headache
|
12 participants
|
17 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Constipation
|
21 participants
|
21 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Oversedation
|
14 participants
|
8 participants
|
|
Number of Participants Reporting Side Effects During the Post-tonsillectomy Recovery Period.
Tonsil bleed
|
3 participants
|
0 participants
|
Adverse Events
Capital® With Codeine Suspension
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Tramadol Suspension
Serious events: 1 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Capital® With Codeine Suspension
n=38 participants at risk；n=42 participants at risk
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
|
Tramadol Suspension
n=36 participants at risk；n=42 participants at risk
Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
|
|---|---|---|
|
Blood and lymphatic system disorders
Tonsil bleed requiring hospitalization
|
2.4%
1/42 • Number of events 1
|
0.00%
0/42
|
|
General disorders
Throat pain requiring hospitalization
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
General disorders
Dehydration
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
|
Gastrointestinal disorders
Difficulty with oral intake
|
0.00%
0/42
|
2.4%
1/42 • Number of events 1
|
Other adverse events
| Measure |
Capital® With Codeine Suspension
n=38 participants at risk；n=42 participants at risk
Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg \[=0.3 mL/kg\] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
|
Tramadol Suspension
n=36 participants at risk；n=42 participants at risk
Tramadol suspension : Liquid tramadol 1.05 mg/kg \[=0.3 mL/kg\] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
|
|---|---|---|
|
Nervous system disorders
Nausea
|
52.6%
20/38
|
55.6%
20/36
|
|
Gastrointestinal disorders
Vomiting
|
55.3%
21/38
|
50.0%
18/36
|
|
Infections and infestations
Fever
|
28.9%
11/38
|
27.8%
10/36
|
|
Skin and subcutaneous tissue disorders
Itching
|
13.2%
5/38
|
33.3%
12/36
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.6%
1/38
|
2.8%
1/36
|
|
General disorders
Sweating
|
23.7%
9/38
|
19.4%
7/36
|
|
Nervous system disorders
Dizziness
|
39.5%
15/38
|
47.2%
17/36
|
|
Nervous system disorders
Headache
|
31.6%
12/38
|
47.2%
17/36
|
|
Gastrointestinal disorders
Constipation
|
55.3%
21/38
|
58.3%
21/36
|
|
General disorders
Oversedation
|
36.8%
14/38
|
22.2%
8/36
|
|
Blood and lymphatic system disorders
Tonsil bleed
|
5.3%
2/38
|
0.00%
0/36
|
Additional Information
Andrea Postier/Clinical Research Program Manager
Children's Hospitals and Clinics of Minnesota
Phone: 612-813-6409
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place