Adults 1 Day to 23 Months, any sex, with Moderate to Severe Acute Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 YearsPrimary· Up to 8 hours after IMP administration
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quant
30 minutes after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
9.8
± 5.21
1 hour after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
18.79
± NA
2 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
32.2
± 14.92
4 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
11.1
± 5.97
6 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
14.85
± NA
8 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
10.7
± 4.15
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 MonthsPrimary· Up to 8 hours after IMP administration
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quant
30 minutes after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
8.3
± 6.30
1 hour after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
35.27
± NA
2 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
27.3
± 0.81
4 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
25.9
± 10.33
6 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
32.75
± NA
8 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
5.6
± 1.81
Pharmacokinetic Evaluation Based on Serum Concentrations of Tapentadol After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 MonthPrimary· Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of Tapentadol were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower limit of quant
30 minutes after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
26.62
± NA
1 hour after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
43.63
± NA
2 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
19.9
± 7.67
4 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
15.0
± 8.92
6 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
18.82
± NA
8 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
14.6
± 6.26
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 6 Months to Less Than 2 YearsPrimary· Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower
30 minutes after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
105.7
± 125.00
1 hour after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
430.7
± NA
2 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
468.0
± 248.41
4 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
348.7
± 228.22
6 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
370.2
± NA
8 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years - PK Set
285.1
± 107.06
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged 1 Month to Less Than 6 MonthsPrimary· Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower
30 minutes after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
128.8
± NA
1 hour after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
136.3
± NA
2 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
324.9
± 116.61
4 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
449.7
± 7.42
6 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
253.3
± NA
8 hours after administration
Group
Value
95% CI
Participants Aged 1 Month to Less Than 6 Months - PK Set
92.2
± 63.83
Pharmacokinetic Profile of Serum Concentrations of Tapentadol-O-glucuronide After a Single Dose of Tapentadol Oral Solution in Participants Aged From Birth to Less Than 1 MonthPrimary· Up to 8 hours after IMP
The pharmacokinetic profile of Tapentadol and its major metabolite tapentadol-O-glucuronide was evaluated to enable data based recommendations for the use of Tapentadol in children of different ages.
Each participant had a single pharmacokinetic sample taken at up to 2 different pre-defined time points.
Serum was analyzed using liquid chromatography-tandem mass spectrometry. Mean and Standard Deviation of Serum Concentrations of tapentadol-O-glucuronide were calculated.
Summary statistics at a given time point were only determined if at least 2 participants had observations above the lower
30 minutes after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
74.38
± NA
1 hour after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
209
± NA
2 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
98.5
± 2.62
4 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
147.6
± 53.74
6 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
224.8
± NA
8 hours after administration
Group
Value
95% CI
Participants Aged From Birth to Less Than 1 Month - PK Set
174.1
± 11.03
Change From Baseline (Visit 1, After Surgery) in Pain IntensitySecondary· Baseline; up to 15 hours after study medication
The change from baseline in pain intensity using the Face, Legs, Activity, Cry, Consolability Scale (FLACC Scale) at 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, and 15 hours after a single dose of tapentadol.
The FLACC Scale is a behavioral scale for scoring postoperative pain in young children. It includes five categories of pain behaviors, including facial expression, leg movement, activity, cry, and consolability. The scale is scored in a range of 0-10 with 0 representing no pain.
The pain intensity scores were summarized descriptively per scheduled time
15 minutes after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-0.8
± 3.1
Participants Aged 1 Month to Less Than 6 Months.
-1.3
± 2.8
Participants Aged From Birth to Less Than 1 Month.
-1.6
± 1.5
30 minutes after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-1.1
± 2.6
Participants Aged 1 Month to Less Than 6 Months.
-3.0
± 3.6
Participants Aged From Birth to Less Than 1 Month.
-1.4
± 1.5
1 hour after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-2.0
± 3.6
Participants Aged 1 Month to Less Than 6 Months.
-2.7
± 4.5
Participants Aged From Birth to Less Than 1 Month.
0.0
± 3.7
2 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-2.8
± 2.9
Participants Aged 1 Month to Less Than 6 Months.
-3.0
± 3.9
Participants Aged From Birth to Less Than 1 Month.
-0.4
± 2.6
4 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-1.6
± 3.4
Participants Aged 1 Month to Less Than 6 Months.
-2.2
± 3.3
Participants Aged From Birth to Less Than 1 Month.
-0.4
± 2.3
6 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-1.9
± 3.1
Participants Aged 1 Month to Less Than 6 Months.
-1.7
± 4.8
Participants Aged From Birth to Less Than 1 Month.
-0.4
± 2.3
8 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-2.5
± 2.5
Participants Aged 1 Month to Less Than 6 Months.
-3.0
± 3.2
Participants Aged From Birth to Less Than 1 Month.
-1.2
± 1.1
12 hours after administration
Group
Value
95% CI
Participants Aged 6 Months to Less Than 2 Years.
-2.4
± 2.8
Participants Aged 1 Month to Less Than 6 Months.
-3.5
± 3.8
Participants Aged From Birth to Less Than 1 Month.
-1.4
± 1.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Any Adverse Events (AE) that started on the intake of the IMP (investigational medicinal product) up to the end of the therapeutic reach of the IMP. Any pre-treatment AE which worsened (change in intensity, frequency or quality) after IMP administration compared to the complaint present before IMP intake have been recorded as a new AE..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Participants Aged 6 Months to Less Than 2 Years.
Serious: 0/8 (0%)
Deaths: 0/8
Participants Aged 1 Month to Less Than 6 Months.
Serious: 0/6 (0%)
Deaths: 0/6
Participants Aged From Birth to Less Than 1 Month.
This is a multicenter, open-label (all people involved know the identity of the intervention), single dose trial to evaluate the pharmacokinetic (PK) profile (how drugs are absorbed in the body, how are they distributed within the body and how are they removed from the body over time) in children aged from birth to less than 2 years after a surgical procedure that routinely produces moderate to severe acute post-surgical pain.
The trial will also evaluate the safety and tolerability of tapentadol oral solution in the population studied and the effect of tapentadol oral solution on pain.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Grünenthal GmbH
Last refreshed: 29 January 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02221674.