Postoperative Pain
Conditions
Keywords
Postoperative pain, Hydromorphone oral solution, opioid, pharmacokinetics, pharmacodynamics
Brief summary
The primary objective of this study is to characterize the pharmacokinetics and pharmacodynamics of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive. The secondary objectives are to characterize the safety and efficacy of hydromorphone oral solution in pediatric subjects aged 28 days to 16 years inclusive.
Detailed description
Hydromorphone is an opioid analgesic that has been used for decades as an alternative to morphine in the treatment of moderate to severe malignant and nonmalignant pain. Only a small number of analgesics have been studied in children. The benefits to the subjects include contribution of knowledge that will provide for appropriate dosing regimen recommendations for future pediatric subjects. Treatment consisted of both parenteral and oral hydromorphone. For up to 48 hours immediately following surgery, subjects were administered hydromorphone by IV PCA pump. Dosing with the oral hydromorphone HCl began when the subject was ready to take clear oral liquid. Subjects were administered oral hydromorphone HCl every 6 hours for up to 9 doses. The investigator determined the timing of the first dose based on each subject's clinical condition. The duration of the treatment phase was up to 102 hours (up to 48 hours for the Parenteral Treatment Period and up to 54 hours for the Oral Treatment Period). Efficacy was based on the oral hydromorphone treatment. Adverse events were collected for both the oral and parenteral treatments.
Interventions
DRUGHydromorphone
Oral hydromorphone solution dosed every 6 hours up to 9 doses. Dose is determined based on the expected weight range for each age group.
Sponsors
Purdue Pharma LP
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
28 Days to 16 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric subjects aged 28 days to 16 years, * Prospective subjects anticipated to have postoperative pain requiring oral opioid analgesics for at least 24 hours (up to 48 hours) following postoperative parenteral analgesia (up to 48 hours), * Prospective subjects have received no more than a total of 7 doses of opioids in the 30 days prior to surgery.
Exclusion criteria
* Prospective subjects with clinically significant hepatic or renal dysfunction and impaired cardiac and/or respiratory reserve, * Prospective subjects who have received opioid analgesic therapy other than hydromorphone or morphine sulfate during the up to 48-hour postoperative period prior to administration of first dose of oral hydromorphone, * Prospective subjects who have received regional anesthetic blockade OR analgesic treatment with nonopioid medication within 6 hours prior to administration of first dose of oral hydromorphone. Other protocol-specific inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl) | A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration. | Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Immediately prior to first oral dose, up to 54 hours | There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills. |
| Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Immediately prior to first oral dose with potentially up to 54 hours duration. | Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills. |
| Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Immediately prior to first oral dose, up to 54 hours | The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age. |
Countries
United States
Participant flow
Recruitment details
23-Apr-2007 (first subject, first visit) to 03-May-2009 (last subject, last visit). Multicenter study conducted at 18 sites in the United States (US).
Pre-assignment details
Subjects who were anticipated to have acute, postoperative pain requiring oral opioid analgesics for at least 24 to 48 hours following postoperative parenteral analgesia.
Participants by arm
| Arm | Count |
|---|---|
| ≥ 28 Days to < 13 Months Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group. | 39 |
| ≥ 13 Months to < 5 Years Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group. | 23 |
| ≥ 5 Years to < 12 Years Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group. | 29 |
| ≥ 12 Years to < 17 Years Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group. | 25 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Administrative | 2 | 2 | 3 | 2 |
| Overall Study | Adverse Event | 2 | 0 | 3 | 2 |
| Overall Study | The other reasons included loss of IV | 8 | 4 | 3 | 2 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 7 |
Baseline characteristics
| Characteristic | ≥ 28 Days to < 13 Months | ≥ 13 Months to < 5 Years | ≥ 5 Years to < 12 Years | ≥ 12 Years to < 17 Years | Total |
|---|---|---|---|---|---|
| Age, Continuous | 5.9 months STANDARD_DEVIATION 2.76 | 33.6 months STANDARD_DEVIATION 14.9 | 105.9 months STANDARD_DEVIATION 27.06 | 178.3 months STANDARD_DEVIATION 17.05 | 73.5 months STANDARD_DEVIATION 69.32 |
| Race/Ethnicity, Customized Asian | 5 participants | 3 participants | 1 participants | 0 participants | 9 participants |
| Race/Ethnicity, Customized Black or African American | 6 participants | 2 participants | 10 participants | 5 participants | 23 participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 0 participants | 1 participants | 0 participants | 0 participants | 1 participants |
| Race/Ethnicity, Customized White | 28 participants | 16 participants | 18 participants | 20 participants | 82 participants |
| Sex: Female, Male Female | 18 Participants | 10 Participants | 14 Participants | 18 Participants | 60 Participants |
| Sex: Female, Male Male | 21 Participants | 13 Participants | 15 Participants | 7 Participants | 56 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 21 / 39 | 14 / 23 | 15 / 29 | 6 / 25 | 27 / 39 | 16 / 23 | 19 / 29 | 17 / 25 |
| serious Total, serious adverse events | 2 / 39 | 2 / 23 | 1 / 29 | 0 / 25 | 3 / 39 | 0 / 23 | 1 / 29 | 1 / 25 |
Outcome results
Primary
Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl)
Model was built using sparse blood samples: Sampling times: immediately predose, and between 0.25-0.75, 1-3, and 4-6 hours postdose for the first 2 doses of oral hydromorphone: predose for each dose of oral hydromorphone HCl thereafter; and at the end of study. Efficacy was based on Oral treatment only.
Time frame: A maximum of 9 oral hydromorphone doses with potentially up to 54 hours duration.
Population: The full analysis population for Pharmacokinetics/ Pharmacodynamics consisted of subjects who received at least 1 dose of oral hydromorphone HCl, and had at least 1 valid quantifiable PK sample. To be a valid sample, the time of administration of each dose of oral hydromorphone HCl, the dose, and the time of sample collection must be recorded.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| All Patients | Population Pharmacokinetic/Pharmacodynamic (PK/PD) Model for Hydromorphone: Clearance (Cl) | 114 L/hour |
Secondary
Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years]
There are 5 categories in this pediatric pain measurement: face, legs, activity, cry, and consolability. Responses in each category are scored between 0 and 2 (0 = normal, relaxed to 2 = upset, agitated), for a maximum total score of 10. The FLACC scale was used for children under the age of 3 years and older children who have limited verbal skills.
Time frame: Immediately prior to first oral dose, up to 54 hours
Population: The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 1 (1 hour postdose) | 1.13 units on a scale | Standard Error 0.335 |
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 4 (1 hour postdose) | 0.55 units on a scale | Standard Error 0.274 |
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 3 (1 hour postdose) | 0.27 units on a scale | Standard Error 0.117 |
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Predose | 1.34 units on a scale | Standard Error 0.388 |
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 6 (1 hour postdose) | 0.61 units on a scale | Standard Error 0.465 |
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 5 (1 hour postdose) | 0.70 units on a scale | Standard Error 0.333 |
| All Patients | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 2 (1 hour postdose) | 0.57 units on a scale | Standard Error 0.223 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 3 (1 hour postdose) | 0.93 units on a scale | Standard Error 0.715 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Predose | 2.67 units on a scale | Standard Error 0.558 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 1 (1 hour postdose) | 1.07 units on a scale | Standard Error 0.483 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 2 (1 hour postdose) | 0.67 units on a scale | Standard Error 0.333 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 4 (1 hour postdose) | 0.85 units on a scale | Standard Error 0.608 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 5 (1 hour postdose) | 0.09 units on a scale | Standard Error 0.091 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 6 (1 hour postdose) | 1.20 units on a scale | Standard Error 0.854 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 4 (1 hour postdose) | 0.40 units on a scale | Standard Error 0.4 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 1 (1 hour postdose) | 2.17 units on a scale | Standard Error 0.872 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 6 (1 hour postdose) | 0.75 units on a scale | Standard Error 0.479 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 5 (1 hour postdose) | 1.00 units on a scale | Standard Error 0.577 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 3 (1 hour postdose) | 0.75 units on a scale | Standard Error 0.75 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Dose 2 (1 hour postdose) | 1.20 units on a scale | Standard Error 0.583 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces, Legs Activity, Cry, Consolability (FLACC) Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time [Ages >=28 Days to <5 Years] | Predose | 2.71 units on a scale | Standard Error 0.522 |
Secondary
Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time
Faces Pain Scale-Revised (FPS-R) consists of 6 facial expressions. Each face is 25 x 35 mm with 13 mm between faces. Each subject was asked to point to the face that reflected his or her pain. The end points are 0 = no pain and 10 = very much pain. The FPS-R scale was used for children over the age of 5 up to 12 years who have appropriate verbal skills.
Time frame: Immediately prior to first oral dose with potentially up to 54 hours duration.
Population: The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 2 (1 hour postdose) | 1.33 units on a scale | Standard Error 1.333 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 4 (1 hour postdose) | 0 units on a scale | Standard Error 0 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 1 (1 hour postdose) | 1.20 units on a scale | Standard Error 1.2 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 5 (1 hour postdose) | 0 units on a scale | Standard Error 0 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 3 (1 hour postdose) | 2.67 units on a scale | Standard Error 0.667 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 6 (1 hour postdose) | 0 units on a scale | Standard Error 0 |
| Oral ≥ 13 Months to < 5 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Predose | 1.50 units on a scale | Standard Error 0.957 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 6 (1 hour postdose) | 0.40 units on a scale | Standard Error 0.4 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Predose | 2.59 units on a scale | Standard Error 0.446 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 1 (1 hour postdose) | 2.25 units on a scale | Standard Error 0.772 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 2 (1 hour postdose) | 0.92 units on a scale | Standard Error 0.431 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 3 (1 hour postdose) | 1.54 units on a scale | Standard Error 0.514 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 4 (1 hour postdose) | 1.86 units on a scale | Standard Error 0.71 |
| Oral ≥ 5 Years to < 12 Years | Mean (SE) of Faces Pain Scale-Revised (FPS-R) [Ages >= 5 Years-< 12 Years] Pain Scores on Hydromorphone Alone (Oral/Supplemental)Over Time | Dose 5 (1 hour postdose) | 1.64 units on a scale | Standard Error 0.845 |
Secondary
Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time
The Visual Analog Scale (VAS), a 10-cm Color Analog Scale anchored by the descriptors of 0 = no pain and 10 = most pain, was used by children ≥ 12 years of age.
Time frame: Immediately prior to first oral dose, up to 54 hours
Population: The Full Analysis Population for Efficacy consisted of subjects who received at least 1 dose of oral hydromorphone HCl and had at least 1 subsequent efficacy evaluation (pain measurement or supplemental pain medication).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Predose | 4.04 unit on a scale | Standard Error 0.53 |
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Dose 1 (1 hour postdose) | 3.73 unit on a scale | Standard Error 0.629 |
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Dose 2 (1 hour postdose) | 3.95 unit on a scale | Standard Error 0.673 |
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Dose 3 (1 hour postdose) | 4.09 unit on a scale | Standard Error 0.569 |
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Dose 4 (1 hour postdose) | 4.13 unit on a scale | Standard Error 0.599 |
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Dose 5 (1 hour postdose) | 4.19 unit on a scale | Standard Error 0.945 |
| Oral ≥ 12 Years to < 17 Years | Mean (SE) of Visual Analog Scale (VAS) [Ages 12-16] Pain Scores on Hydromorphone Alone (Oral/Supplemental) Over Time | Dose 6 (1 hour postdose) | 3.25 unit on a scale | Standard Error 0.998 |