Medrol for Postoperative Pain

Age: < 65
Sex: Any
Trial Phase: Phase < 1
Sponsor: University of Utah

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Medrol, a type of steroid, can manage pain after surgery for Adolescent Idiopathic Scoliosis (AIS) and reduce hospital stay time. Participants will receive either Medrol tablets or placebo tablets (lookalikes with no active medicine) after surgery. The trial aims to determine if Medrol reduces pain and allows earlier hospital discharge. It suits individuals aged 10 to 21 who have undergone surgery for AIS. As an Early Phase 1 trial, this research focuses on understanding Medrol's effects in people, offering participants a chance to contribute to groundbreaking insights.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications.

Is there any evidence suggesting that Medrol is likely to be safe for humans?

Research shows that Medrol, also known as methylprednisolone, is generally safe. Studies have found it effectively reduces pain after surgery. In one study, patients who took Medrol reported less pain compared to those who didn't. Another study showed it reduced the need for painkillers and their side effects.

While these findings support Medrol's safety, this trial remains in an early stage. Researchers are still closely monitoring and collecting safety information. Medrol is also an FDA-approved steroid for other conditions, which adds reassurance about its safety. However, like any medication, side effects may occur, so discussing concerns with the research team is advisable.12345

Why do researchers think this study treatment might be promising?

Medrol is unique because it offers a tapered dosage approach to managing postoperative pain with a steroid. Unlike standard options like opioids or nonsteroidal anti-inflammatory drugs (NSAIDs), Medrol uses methylprednisolone, which reduces inflammation and may help minimize pain without the risk of addiction associated with opioids. Researchers are excited about Medrol because it could provide effective pain relief with fewer side effects and a reduced chance of long-term dependence, offering a promising alternative for postoperative care.

What evidence suggests that Medrol might be an effective treatment for postoperative pain in Adolescent Idiopathic Scoliosis?

This trial will compare Medrol tablets with placebo tablets for managing postoperative pain. Research has shown that Medrol, a type of steroid, can reduce pain and the need for strong painkillers after surgeries like total knee replacement. One study found it significantly lowered pain levels and reduced the need for painkillers after surgery. Another study found that Medrol was as effective as ketorolac, another pain relief drug, in reducing early pain. However, some research suggests its effect on early pain and recovery can vary depending on the type of surgery. While not all studies agree, evidence indicates that Medrol could help manage pain after certain surgeries.12467

Who Is on the Research Team?

JK

Joshua Klatt, M.D.

Principal Investigator

University of Utah Orthopaedics

Are You a Good Fit for This Trial?

This trial is for young individuals aged 10-21 who have undergone surgery for Adolescent Idiopathic Scoliosis (AIS). It's not open to those outside this age range or those with other forms of scoliosis.

Inclusion Criteria

I am between 10 and 21 years old.
Received AIS surgery

Exclusion Criteria

I am not between the ages of 10 and 21.
My condition is a type of scoliosis that is not adolescent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Medrol tablets or placebo tablets for post-operative pain control following AIS surgery

6 days
Daily visits for medication administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medrol
Trial Overview The study is testing whether a short course of steroids, specifically Medrol dose packs, can help manage pain better and reduce the time patients stay in the hospital after AIS surgery compared to a placebo.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Medrol tabletsExperimental Treatment1 Intervention
Group II: Placebo tabletsPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/31743165/
Methylprednisolone Does Not Reduce Acute Postoperative ...There are currently no data to suggest that methylprednisolone has significant analgesic benefit in adults having cardiac surgery.
The efficacy and safety of methylprednisolone for pain ...Methylprednisolone could significantly decrease postoperative pain score, narcotic consumption and opioid-related adverse effects after TKA.
3.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/15504180/
Methylprednisolone intravenously 1 day after surgery has ...Conclusion: Methylprednisolone 125 mg i.v. 1 day after surgery gave similar early reduction of pain as i.v. ketorolac 30 mg. Less pain than placebo 24 h after ...
Effects of methylprednisolone on early postoperative pain ...Our findings suggested that preoperative methylprednisolone (either high or low dose) has limited impact on early postoperative pain and recovery.
Efficacy of Methylprednisolone for Pain Control After ACL ...The purpose of this study is to investigate the impact of adding a methylprednisolone taper to the pain regimen after ACL repair surgery to determine if this ...
a retrospective single-center study - PMC - PubMed CentralOur results showed that postoperative intravenous methylprednisolone administration reduces postoperative pain: VAS pain scores and ODI ...
Association between postoperative intravenous ...Our results showed that postoperative intravenous methylprednisolone administration reduces postoperative pain: VAS pain scores and ODI scores ...
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