Pharmacokinetic, Efficacy and Safety Study of Tapentadol Oral Solution in Children With Postoperative Pain
Condition: Postoperative Pain; Acute Pain
MeSH terms: Pain, Postoperative; Acute Pain
Intervention: Tapentadol
Intervention description: Tapentadol oral solution single dose (1mg/kg body weight)
Intervention MeSH terms: Tapentadol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 86.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Tonsillectomy; Dental surgery; Ear surgery; Nose surgery; Throat surgery

Summary:

      To find out if a drug called tapentadol administered by mouth safely relieves pain in
      children. Look at the amount of tapentadol in the blood after a single oral dose.

      Tapentadol oral solution for children is still being tested and is not yet registered.
      Tapentadol tablets are effective in treating both acute and chronic pain in adults. This
      trial will help to understand how tapentadol oral solution works in children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A maximum body weight of 85.0 kg.

          -  A minimum body weight of 10 kg for participants aged 2 years to less than 3 years old.

          -  If female and post-menarchal, or 12 years or older, the subject has a negative urine
             pregnancy test within 24 hours before surgery.

          -  Having completed either dental surgery or tonsillectomy with or without adenoidectomy
             surgery (age group: 6 to less than 18 years of age).

          -  Having completed ear, nose, or throat surgery (including but not limited to
             tonsillectomy (age group: 2 to less than 3 years of age).

          -  Participant aged 6 to less than 18 years has a post-operative pain intensity score
             greater than or equal to 4 on the Color Analog Scale (CAS) as a result of the surgical
             procedure or the participant has a pain level that the usual standard of care
             following the surgical procedure (which reliably produces moderate to severe pain)
             requires opioid treatment.

          -  Participant aged 2 years to less than 6 years has a pain level following a surgical
             procedure that reliably produces moderate to severe pain, for which the usual standard
             of care requires opioid treatment.

          -  Participant is alert, orientated, and able to follow commands and complete the
             post-operative required procedures.

        Exclusion Criteria:

          -  History of brain injury.

          -  Clinically relevant abnormal ECG.

          -  Clinically unstable vital signs and/or a saturation of oxygen saturation (SpO2) less
             than 93%. During surgery SpO2 may decrease <93%.

          -  Clinically relevant abnormal values for clinical chemistry, hematology, or urinalysis
             at enrollment.

          -  Body temperature above 38.5°C within 48 hours prior to dosing.

          -  Positive drugs of abuse test result.