A Study to Look at Tapentadol Oral Solution in Children and Adolescents in Pain
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study was to evaluate the efficacy of tapentadol oral solution, based on
      the total amount of supplemental opioid analgesic used over 12 hours or 24 hours after
      initiation of investigational medicinal product (IMP) in children and adolescents who had
      undergone surgery that would produce moderate to severe pain during opioid treatment.
    

Detailed description: 
      The supplemental opioid medication reflecting the standard of care was available as patient-
      or nurse-controlled intravenous (i.v.) morphine or hydromorphone. This supplemental opioid
      analgesic medication (SOAM) was given to control pain, as needed, in both the treatment and
      placebo groups.

      Children and adolescents 6 months and older were dosed with a dose regimen of 1.25 mg/kg body
      weight for the first 24 hours of treatment. 24 hours after the start of study medication (and
      based on clinical judgment), a dose reduction to 1.0 mg/kg was allowed.

      Participants 30 days to less than 6 months old were dosed with a regimen of 0.5 mg/kg for the
      first 24 hours of treatment. The dose of IMP could be reduced after 24 hours to 0.3 mg/kg (if
      there was a reduced need for analgesia according to the investigator's judgment).

      Participants aged from birth to less than 30 days old were dosed with a regimen of 0.1 mg/kg
      for the first 24 hours of treatment. The dose of the IMP could be reduced after 24 hours to
      0.075 mg/kg (if there was a reduced need for analgesia according to the investigator's
      judgment).

      The decision to maintain or alter the dose based on the effectiveness of the analgesia (pain
      killer) and the adverse event profile observed in each participant over the first 24-hour
      dosing period was made based on the investigator's judgment.

      In exceptional cases, if a participant had unbearable pain despite using nurse-controlled
      analgesia (NCA) or patient-controlled analgesia (PCA), an additional bolus (defined as a
      clinician bolus) of morphine or hydromorphone could have been administered. The clinician
      bolus could have been given either using the NCA/PCA pump system or by an intravenous bolus
      injection. The opioid given as a clinician bolus or if the NCA/PCA intravenous line failed,
      had to be the same opioid used in the NCA/PCA pump system.

      Dosing with IMP was stopped if:

        -  A switch to exclusively oral opioid analgesic medication was indicated according to the
           local standard of care.

        -  Opioid analgesic medication was no longer needed.

        -  IMP had been administered for 72 hours.

      Safety evaluations included assessment of adverse events, physical examination, vital signs,
      laboratory parameters, electrocardiogram, oxygen saturation, and, only for children older
      than 6 years of age, a scale to assess suicidal ideation (Columbia Suicide Severity Rating
      Scale [C-SSRS]). The maximum study duration for each participant was 42 days.

      The evaluation of the safety and efficacy data was performed by age groups as aligned with
      European and United States agencies. Within the tapentadol treatment group, no analysis by
      tapentadol dose was conducted. Results for participants aged 2 years to <18 years were
      provided to the Pediatric Committee of the European Medicines Agency (EU PDCO) before
      recruitment of the children less than 6-month old required for the US Food and Drug
      Administration [FDA] analysis was completed. Participants from birth to <2 years old were
      analyzed separately for the US FDA only and not included in the analysis of the population
      aged from 2 years to <18 years.
    

Intervention name(s): Tapentadol oral solution 4 mg/mL; Tapentadol oral solution 20 mg/mL; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants aged 6 months to less than 18 years old with a body weight below 20 kg received tapentadol oral solution 4 mg/mL by mouth every 4 hours for up to 72 hours.
Participants from birth to less than 6 months received tapentadol oral solution, diluted 4 fold.; Participants aged from 6 months to less than 18 years with a body weight greater than or equal to 20 kg received tapentadol oral solution 20 mg/mL by mouth every 4 hours for up to 72 hours.; Matching placebo oral solution was administered by mouth every 4 hours up to 72 hours.
Intervention MeSH terms: Tapentadol; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Pain; Post-operative; Tapentadol; Opioid Treatment; Pediatric Participants