A Phase 2 interventional study of Hydromorphone in Pain, sponsored by Columbia University. Completed at 1 site in United States. Open to participants aged 4 Years to 17 Years. Per ClinicalTrials.gov, last updated 2019-05-28.
Sponsored by Columbia University · Phase 2, Interventional, and Treatment
Intranasal hydromorphone has been shown to be effective in reducing acute pain in adults. It has not been previously studied in children, but may be a viable option for effectively and safely reducing pain in children by administering an analgesic by the intranasal route.
This study will be a prospective, open-label pilot study of intranasal hydromorphone in children with moderate to severe acute pain presenting to the pediatric emergency department. The investigators aim to describe the amount of pain reduction associated with intranasal hydromorphone, and to determine the optimal dose of intranasal hydromorphone associated with a clinically meaningful improvement in acute pain.
Primary Aim: Determine the change in pain intensity in children with moderate to severe pain who receive intranasal hydromorphone one hour after administration.
Secondary Aim(s): Describe the incidence of minor and major adverse events associated with intranasal hydromorphone in children with acute pain.
The investigators will assess the patient's pain at baseline (prior to study drug administration), then after study drug administration: 5 minutes, 15 minutes, 30 minutes, 45 minutes, 60 minutes, and then every 30 minutes thereafter until 6 hours; administration of non-protocolized rescue medication administration (i.e. administered after first two rescue doses of IN hydromorphone); or discharge from emergency department (whichever comes first). The pain score at 60 minutes will be the primary outcome.
The investigators will evaluate qualitative improvement in pain intensity at 15- and 30-minutes after study drug administration. If there is no improvement, or worsening of pain intensity, at each assessment, an additional rescue dose rescue dose of intranasal hydromorphone will be administered. After 60 minutes, the treating physician may administer any additional rescue medications at their discretion to treat the child's pain.
The patient will be assessed for minor and major adverse events for the duration of the study.
876 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 35 is below the median of 90 across 732 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →Columbia University is the lead sponsor of 1,103 studies on the registry; 193 are open to participants now.
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Exclusion Criteria:
Hydromorphone, intranasal. 2 mg/mL concentration. Initial dose: 0.03 mg/kg, maximum single dose 4 mg. Rescue dose: 0.015 mg/kg, maximum single dose 2 mg.
Drug: Hydromorphone
To be administered by intranasal route using mucosal atomization device.
Also known as: Dilaudid
Score on Faces Pain Scale - Revised
Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM
Time frame: 1 hour
Number of Minor Adverse Events
Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.
Time frame: 6 hours
Number of Major Adverse Events
Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.
Time frame: 6 hours
Score on Verbal Numeric Rating Scale
Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU
Time frame: 1 hour
| Milestone | Intranasal Hydromorphone |
|---|---|
| Started | 35 |
| Completed | 35 |
| Not completed | 0 |
Pain was measured using the Faces Pain Scale - Revised (FPS-R). The FPS-R is a self-reported measure of pain that is administered using a picture of 6 different faces lined up in a row, each face representing an escalating degree of pain intensity. The faces, starting from the left-most face and moving towards the right-most face, are scored 0, 2, 4, 6, 8 and 10. A score of 0 represents no pain, a score of 10 represents "very much pain" (i.e. maximum possible pain). More information about the FPS-R can be found here: https://bit.ly/2VPk8GM
| units on a scale | Intranasal Hydromorphone |
|---|---|
| Score on Faces Pain Scale - Revised | 4.7 (3.7 to 5.7) |
Lightheadedness, dizziness; confusion; sleepy, drowsy, tiredness; nausea; vomiting; itchiness, warm sensation; dry mouth; bad taste in mouth; rhinitis.
| Minor adverse events | Intranasal Hydromorphone |
|---|---|
| Number of Minor Adverse Events | 39 |
Oxygen desaturation, respiratory depression, hypotension, bradycardia, need for supplemental oxygen, bag-mask ventilation, airway support intervention, administration naloxone.
| Major adverse events | Intranasal Hydromorphone |
|---|---|
| Number of Major Adverse Events | 0 |
Pain was measured using the Verbal Numerical Rating Scale (VNRS). The VNRS is a self-reported measure of pain that is administered verbally by asking a patient to rate their pain on a scale from 0 to 10, with 0 representing no pain, and 10 representing maximum pain. More information about the VNRS in children can be found here: https://bit.ly/2VZ7aWU
| units on a scale | Intranasal Hydromorphone |
|---|---|
| Score on Verbal Numeric Rating Scale | 5.1 (4.2 to 6) |
Collected over 6 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intranasal Hydromorphone | 0/35 (0%) | 0/35 (0%) | 22/35 (62.9%) |
| Event | Intranasal Hydromorphone |
|---|---|
| Sleepy, drowsy, or tiredGeneral disorders | 11/35 |
| Bad taste in mouthGeneral disorders | 8/35 |
| Lightheaded, dizzyGeneral disorders | 8/35 |
| Dry mouthGeneral disorders | 5/35 |
| RhinitisGeneral disorders | 3/35 |
| NauseaGeneral disorders | 2/35 |
| ConfusionNervous system disorders | 1/35 |
| ItchinessSkin and subcutaneous tissue disorders | 1/35 |
| VomitingGastrointestinal disorders | 0/35 |
| Warm sensationGeneral disorders | 0/35 |
| Age, Continuous(years) | Intranasal Hydromorphone |
|---|---|
| Median | 11 (8 to 14) |
| Sex: Female, Male(Participants) | Intranasal Hydromorphone |
|---|---|
| Female | 13 |
| Male | 22 |
| Race/Ethnicity, Customized(Participants) | Intranasal Hydromorphone |
|---|---|
| Hispanic | 26 |
| White | 5 |
| Black | 3 |
| More than one race | 1 |
| Baseline pain score(units on a scale) | Intranasal Hydromorphone |
|---|---|
| Mean | 7 ± 0.4 |
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