Pain ControlPhase 4NCT05552443
A Study of Intrathecal Hydromorphone for Pediatric Idiopathic Scoliosis Repair
A Phase 4 study testing Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg and Hydromorphone 3 mcg/kg in people with Pain Control, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Pain Control
- What is being tested?
- Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg and Hydromorphone 3 mcg/kg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2023to 31 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.
Who cannot join
- Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
- Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
- Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Identification of the Optimal Analgesic Dose of Intrathecal Hydromorphone for Pediatric Patients Undergoing Posterior Spine Surgery for Idiopathic Scoliosis
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
Read the detailed description
This study is a sequential coin based up-down dose allocation method with the goal of identifying the ED90 for intrathecal hydromorphone (ITH) in idiopathic adolescent scoliosis repair via the posterior approach. A starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used ITM doses in pediatric spine patients. Subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. Steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. Steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. A maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. Each patient was assigned to a weight-based dose arm, between 3.5mcg/kg-7.0mcg/kg or up to a maximum of 400 mcg. The anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level.
ITH dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. Efficacious ITH administration will be defined as all NRS scores ≤5 within the first 18 hours after administration (binary outcome). If the NRS score was >5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. If the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. Patients excluded after randomization will be removed from the study.
- Conditions
- Pain Control
- Being tested
- Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg, Hydromorphone 3 mcg/kg, Hydromorphone 3.25 mcg/kg, Hydromorphone 3.5 mcg/kg
- Keywords
- Posterior Spine Surgery, Pediatric Idiopathic Scoliosis Repair
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydromorphone 2.5 mcg/kgDrug
2.5 mcg/kg intrathecal
Hydromorphone 2.75 mcg/kgDrug
2.75 mcg/kg intrathecal
Hydromorphone 3 mcg/kgDrug
3 mcg/kg intrathecal
Hydromorphone 3.25 mcg/kgDrug
3.25 mcg/kg intrathecal
Hydromorphone 3.5 mcg/kgDrug
3.5 mcg/kg intrathecal
Hydromorphone 4 mcg/kgDrug
4 mcg/kg intrathecal
Hydromorphone 4.5 mcg/kgDrug
4.5 mcg/kg intrathecal
Hydromorphone 5 mcg/kgDrug
5 mcg/kg intrathecal
Hydromorphone 5.5 mcg/kgDrug
5.5 mcg/kg intrathecal
Hydromorphone 6 mcg/kgDrug
6 mcg/kg intrathecal
Hydromorphone 6.5 mcg/kgDrug
6.5 mcg/kg intrathecal
Hydromorphone 7 mcg/kgDrug
7 mcg/kg intrathecal
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal Hydromorphone 2.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 2.5 mcg/kg |
| Intrathecal Hydromorphone 2.75 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 2.75 mcg/kg |
| Intrathecal Hydromorphone 3 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 3 mcg/kg |
| Intrathecal Hydromorphone 3.25 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 3.25 mcg/kg |
| Intrathecal Hydromorphone 3.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 3.5 mcg/kg |
| Intrathecal Hydromorphone 4 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 4 mcg/kg |
| Intrathecal Hydromorphone 4.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 4.5 mcg/kg |
| Intrathecal Hydromorphone 5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 5 mcg/kg |
| Intrathecal Hydromorphone 5.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 5.5 mcg/kg |
| Intrathecal Hydromorphone 6 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 6 mcg/kg |
| Intrathecal Hydromorphone 6.5 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 6.5 mcg/kg |
| Intrathecal Hydromorphone 7 mcg/kg | Experimental | Subjects undergoing posterior spinal surgery will receive 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level Receives: Drug: Hydromorphone 7 mcg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (Area Under the Curve Pain)
Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating more severe pain. Pain scores over the first 18 hours were used to calculate the Area Under the Curve (AUC) using the trapezoidal rule.
Measured: 18 hours after intrathecal hydromorphone administration
Secondary outcomes (4)
Number of Subjects Needing Dual Anti-pruritic Agents
The number of subjects who needed dual anti-pruritic agents (Nubain or naloxone (beyond the protocol infusion rate of 0.25 mcg/kg/min)).
Measured: 24 postoperative hours
Maximum Pain Scores
Highest pain score reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with total scores ranging from 0=no pain and 10=worst pain ever with higher scores indicating more severe pain.
Measured: 18 hours after intrathecal hydromorphone administration
Oral Morphine Equivalents Consumption
Total oral morphine equivalents (OME) consumption in the first 24 hours after intrathecal hydromorphone administration. Intrathecal hydromorphone will be included in total oral morphine equivalents consumption.
Measured: 24 hours after intrathecal hydromorphone administration
Number of Subjects Needing Antiemetic Medications Postoperatively
The number of subjects who needed antiemetic medications to prevent or treat nausea and vomiting.
Measured: 24 postoperative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2022
- Study start23 Mar 2023
- Primary completion27 Oct 2024
- Study completion31 Dec 2024
Why it stopped: Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain ControlStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn (Katie) S. Handlogten, Mayo Clinic
- Investigators
- Kathryn Handlogten, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05552443
- Sponsor's protocol ID
- 22-006823
- Status last verified
- May 2026
- First submitted
- 20 Sep 2022
- Last updated
- 14 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of the Optimal Analgesic Dose of Intrathecal Hydromorphone for Pediatric Patients Undergoing Posterior Spine Surgery for Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05552443
- Acronym / sponsor ID
- 22-006823
- Conditions
- Pain Control
- Keywords
- Posterior Spine Surgery, Pediatric Idiopathic Scoliosis Repair
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study participant had a related adverse event that prompted interim data analysis and additional study participants were not sought.
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 27 Oct 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 23 Sep 2022 (actual)
- Results
- Posted 14 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify a dose of intrathecal hydromorphone (opioid pain medicine) that optimizes pain control but minimizes side effects historically seen with this class of pain medications.
Detailed description
This study is a sequential coin based up-down dose allocation method with the goal of identifying the ED90 for intrathecal hydromorphone (ITH) in idiopathic adolescent scoliosis repair via the posterior approach. A starting dose of 3.5 mcg/kg of hydromorphone was determined by current practice at the institution as well as upon review of available literature of previously used ITM doses in pediatric spine patients. Subsequent participants will receive higher (step "up") or lower (step "down") from this starting dose. Steps "down" from the starting dose will be smaller than steps "up" to ensure maintenance of adequate analgesia and to allow more accurate estimate of the optimal dose should it decrease beyond our starting dose. Steps "up" from the starting dose were chosen based on commonly used weight-based doses in our current practice. A maximum dose of 400 mcg, despite patient weight, was determined based on expert consensus and review preparatory to research query. Each patient was assigned to a weight-based dose arm, between 3.5mcg/kg-7.0mcg/kg or up to a maximum of 400 mcg. The anesthesiologist covering the case (high lumbar or thoracic corrections) or the surgeon (low lumbar corrections) will administer the medication at the low lumbar level.
ITH dose adjustments for subsequent study patients will be based on the efficacy of the dose used with the prior patient. Efficacious ITH administration will be defined as all NRS scores ≤5 within the first 18 hours after administration (binary outcome). If the NRS score was >5 within 18 hours or if the patient required supplemental opioid administration for pain control (suggestive of insufficient analgesia), the dose will be increased for the next enrolled study patient. If the pain score remains ≤5 within 18 hours of opioid administration, the next patient will receive the next lower dose or the same dose as the previous patient. Patients excluded after randomization will be removed from the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Intrathecal Hydromorphone 2.5 mcg/kg | Experimental | Drug: Hydromorphone 2.5 mcg/kgSubjects undergoing posterior spinal surgery will receive 2.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 2.75 mcg/kg | Experimental | Drug: Hydromorphone 2.75 mcg/kgSubjects undergoing posterior spinal surgery will receive 2.75 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 3 mcg/kg | Experimental | Drug: Hydromorphone 3 mcg/kgSubjects undergoing posterior spinal surgery will receive 3 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 3.25 mcg/kg | Experimental | Drug: Hydromorphone 3.25 mcg/kgSubjects undergoing posterior spinal surgery will receive 3.25 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 3.5 mcg/kg | Experimental | Drug: Hydromorphone 3.5 mcg/kgSubjects undergoing posterior spinal surgery will receive 3.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 4 mcg/kg | Experimental | Drug: Hydromorphone 4 mcg/kgSubjects undergoing posterior spinal surgery will receive 4 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 4.5 mcg/kg | Experimental | Drug: Hydromorphone 4.5 mcg/kgSubjects undergoing posterior spinal surgery will receive 4.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 5 mcg/kg | Experimental | Drug: Hydromorphone 5 mcg/kgSubjects undergoing posterior spinal surgery will receive 5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 5.5 mcg/kg | Experimental | Drug: Hydromorphone 5.5 mcg/kgSubjects undergoing posterior spinal surgery will receive 5.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 6 mcg/kg | Experimental | Drug: Hydromorphone 6 mcg/kgSubjects undergoing posterior spinal surgery will receive 6 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 6.5 mcg/kg | Experimental | Drug: Hydromorphone 6.5 mcg/kgSubjects undergoing posterior spinal surgery will receive 6.5 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
| Intrathecal Hydromorphone 7 mcg/kg | Experimental | Drug: Hydromorphone 7 mcg/kgSubjects undergoing posterior spinal surgery will receive 7 mcg/kg hydromorphone in the intrathecal space at the low lumbar level |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Undergoing spinal surgery with a posterior approach for idiopathic scoliosis.
Key exclusion criteria (3 listed)
- Patients with pre-surgical elevated pain scores (≥ 3/10 on Numeric Rating Scale (NRS)), history of chronic pain, or pre-surgical opioid use will not be included.
- Patients with contraindications to spinal anesthesia (anatomical abnormality or elevated bleeding or infection risks) will not be included.
- Patients for whom the protocol is violated (inability to perform postoperative data collection), or the study/procedure was aborted will not be included in analysis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydromorphone 2.5 mcg/kg2.5 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 2.5 mcg/kg |
| Hydromorphone 2.75 mcg/kg2.75 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 2.75 mcg/kg |
| Hydromorphone 3 mcg/kg3 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 3 mcg/kg |
| Hydromorphone 3.25 mcg/kg3.25 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 3.25 mcg/kg |
| Hydromorphone 3.5 mcg/kg3.5 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 3.5 mcg/kg |
| Hydromorphone 4 mcg/kg4 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 4 mcg/kg |
| Hydromorphone 4.5 mcg/kg4.5 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 4.5 mcg/kg |
| Hydromorphone 5 mcg/kg5 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 5 mcg/kg |
| Hydromorphone 5.5 mcg/kg5.5 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 5.5 mcg/kg |
| Hydromorphone 6 mcg/kg6 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 6 mcg/kg |
| Hydromorphone 6.5 mcg/kg6.5 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 6.5 mcg/kg |
| Hydromorphone 7 mcg/kg7 mcg/kg intrathecal | Drug | Intrathecal Hydromorphone 7 mcg/kg |
Primary outcome
Pain Intensity (Area Under the Curve Pain)
Time frame: 18 hours after intrathecal hydromorphone administration
Pain intensity reported during the first 18 hours after intrathecal opioid administration. Reported by the patient using an 11-point numeric visual analogue scale (NRS) with 0=no pain and 10=worst pain ever. Subjects were asked to rate their pain approximately 9 different times within the first 18 hours after intrathecal hydromorphone administration. The sum of the patients' pain scores was calculated to determine pain intensity. Total scores ranging from 0 to 90 with higher scores indicating more severe pain. Pain scores over the first 18 hours were used to calculate the Area Under the Curve (AUC) using the trapezoidal rule.
4 secondary outcomes
Number of Subjects Needing Dual Anti-pruritic Agents
Time frame: 24 postoperative hours
Maximum Pain Scores
Time frame: 18 hours after intrathecal hydromorphone administration
Oral Morphine Equivalents Consumption
Time frame: 24 hours after intrathecal hydromorphone administration
Number of Subjects Needing Antiemetic Medications Postoperatively
Time frame: 24 postoperative hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Handlogten, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hydromorphone 2.5 mcg/kg, Hydromorphone 2.75 mcg/kg and Hydromorphone 3 mcg/kg in people with Pain Control, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (Area Under the Curve Pain) (time frame: 18 hours after intrathecal hydromorphone administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.