PainEarly Phase 1NCT06453083
Medrol Dose Packs for Post-Operative Pain Control
A Early Phase 1 study testing Medrol in people with Pain, run by University of Utah at 1 site in United States.
Trial summary
The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay. Read more about this study
- Who is it for?
- Ages 10 to 21 years
- Conditions the study is for
- Pain
- What is being tested?
- Medrol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 17 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age range of 10-21
- received AIS surgery
Who cannot join
- participants out of the age range 10-21
- other forms of scoliosis (not AIS)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
About this study
Official title: Prospective Randomized Trial Using Medrol Dose Packs for Post-Operative Pain Control
The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.
Read the detailed description
Post-operative pain control following AIS surgery is challenging. Sub-optimal pain management results in emotional distress and prolonged hospital length of stay. Previous studies have shown that a short course of steroids following spine surgery is safe and improves pain control. To better understand the effects of the addition of steroids to a routine pain management strategy, a randomized prospective study with and without steroids will determine the benefit, if any, to the addition of steroids to the investigators already used pain protocol.
- Conditions
- Pain
- Being tested
- Placebo, Medrol
- Keywords
- Adolescent Idiopathic Scoliosis (AIS), Steroid, Medrol, Placebo, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo tablets will be dispensed to the participants for 6-days.
MedrolDrug
Also called methylprednisolone
Medrol tablets will be dispensed to the participants for 6-days.
| Study group | Role | What they receive |
|---|---|---|
| Placebo tablets | Placebo comparator | Encapsulated placebo tablets per day (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg.) Receives: Drug: Placebo |
| Medrol tablets | Experimental | Encapsulated steroid Medrol tablets (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg) Receives: Drug: Medrol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Day 2, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Day 3, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Day 4, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Day 5, post (AIS) surgery
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Day 6, post (AIS) surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start13 Jan 2023
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Klatt, University of Utah
- Investigators
- Joshua Klatt, M.D., Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453083
- Sponsor's protocol ID
- 155546
- Status last verified
- Jan 2025
- First submitted
- 5 Jun 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Using Medrol Dose Packs for Post-Operative Pain Control
- ClinicalTrials.gov ID
- NCT06453083
- Acronym / sponsor ID
- 155546
- Conditions
- Pain
- Keywords
- Adolescent Idiopathic Scoliosis (AIS), Steroid, Medrol, Placebo, Pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators primary purpose of this study is to determine if the addition of a short course use of steroids following surgery for Adolescent Idiopathic Scoliosis (AIS) will improve post-operative pain management and shorten hospital length of stay.
Detailed description
Post-operative pain control following AIS surgery is challenging. Sub-optimal pain management results in emotional distress and prolonged hospital length of stay. Previous studies have shown that a short course of steroids following spine surgery is safe and improves pain control. To better understand the effects of the addition of steroids to a routine pain management strategy, a randomized prospective study with and without steroids will determine the benefit, if any, to the addition of steroids to the investigators already used pain protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo tablets | Placebo comparator | Drug: PlaceboEncapsulated placebo tablets per day (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg.) |
| Medrol tablets | Experimental | Drug: MedrolEncapsulated steroid Medrol tablets (dosage for day 1 following the surgery is 32mg, day 2 is 24mg, day 3 is 16mg, day 4 is 12mg, day 5 is 8mg and day 6 is 4mg) |
Who may qualify
- Ages
- 10 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- age range of 10-21
- received AIS surgery
Key exclusion criteria (2 listed)
- participants out of the age range 10-21
- other forms of scoliosis (not AIS)
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 |
|---|---|---|
| PlaceboPlacebo tablets will be dispensed to the participants for 6-days. | Drug | Placebo tablets |
| MedrolAlso: methylprednisoloneMedrol tablets will be dispensed to the participants for 6-days. | Drug | Medrol tablets |
Primary outcome
Visual Analog Scale (VAS) pain
Time frame: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: Day 2, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: Day 3, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: Day 4, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: Day 5, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: Day 6, post (AIS) surgery
VAS pain score (0 no pain - 10 severe pain)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- 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.
Joshua Klatt, M.D. principal investigator
University of Utah Orthopaedics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Medrol in people with Pain, run by University of Utah 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 7 Jan 2025. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Visual Analog Scale (VAS) pain (time frame: Day 1, post Adolescent Idiopathic Scoliosis (AIS) surgery). The study lists 6 primary outcomes in all. 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 7 Jan 2025.