Phase 2 N=35 Treatment

Intranasal Hydromorphone for the Treatment of Acute Pain in Children: A Pilot Study.

Pain

Bottom Line

View on ClinicalTrials.gov: NCT02437669 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2019

Primary outcome: Primary: Score on Faces Pain Scale - Revised — 4.7 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Hydromorphone (Drug)
Age: Pediatric · 4+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Apr 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Score on Faces Pain Scale - Revised	4.7	—
SECONDARY Number of Minor Adverse Events	39	—
SECONDARY Number of Major Adverse Events	—	—
SECONDARY Score on Verbal Numeric Rating Scale	5.1	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Age 4 to 17 years old, inclusive
Moderate to severe pain (i.e. FPS-R or vNRS score of 4 or more)
Requires parenteral opioid analgesic to treat their pain, as decided by treating physician

Exclusion Criteria

Allergy or known contraindication to receiving opioids
Receipt of any opioid or benzodiazepine within preceding 6 hours
Presence of intranasal obstruction that cannot be cleared readily
Cannot speak English or Spanish
Patient unlikely to be able to complete self-report measures of pain or questionnaires
Known liver or kidney problems
Currently critically ill
Chronic pain condition (e.g. sickle cell disease, fibromyalgia)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02437669). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.