Steroids for Post-Tonsillectomy Pain

Overseen By Phayvanh Pecha, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Medical University of South Carolina

Must not be taking: Steroids, Opioids

Disqualifiers: Bleeding disorder, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a single dose of the steroid dexamethasone (also known as Decadron, Dexone, or Hexadrol) can reduce pain after a tonsillectomy, potentially decreasing the need for narcotic pain medications. Participants will receive either the steroid or a placebo (a harmless pill with no active drug) three days after their surgery. The trial is suitable for children aged 3-12 who have undergone a tonsillectomy and returned home the same day. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used steroids for more than three days or any opioids in the 30 days before the tonsillectomy.

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

Research has shown that dexamethasone is usually well-tolerated for post-surgery pain. In studies, patients taking dexamethasone reported less pain, nausea, and vomiting, along with better healing and fewer complications. Importantly, these patients did not experience significant side effects.

However, one study found a higher risk of bleeding with a single dose of dexamethasone during surgery, though other studies did not observe this. In children, dexamethasone reduced early pain and nausea without increasing the risk of post-surgery bleeding.

Overall, dexamethasone appears to be a safe and effective option for managing pain after a tonsillectomy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for post-tonsillectomy pain?

Most treatments for post-tonsillectomy pain involve standard pain relievers like acetaminophen or ibuprofen, which manage discomfort but don't specifically address inflammation that can exacerbate pain. Dexamethasone is unique because it is a steroid that targets inflammation directly, potentially reducing pain more effectively. Researchers are excited about dexamethasone because it is given as a one-time oral dose, which could simplify pain management and enhance recovery on the crucial third post-operative day. This approach might offer faster relief and improved comfort compared to traditional painkillers, making the recovery process smoother for patients.

What evidence suggests that dexamethasone might be an effective treatment for post-tonsillectomy pain?

Research shows that dexamethasone can help reduce pain after tonsil removal. In this trial, participants in the Steroid Group will receive a single dose of dexamethasone, which has lowered pain by about 23% within four hours in previous studies. Those who took dexamethasone also experienced less pain on the third day after surgery. Besides easing pain, dexamethasone alleviated nausea, vomiting, and aided overall recovery, with no reported side effects. Overall, dexamethasone appears promising for managing symptoms after tonsil surgery and may reduce the need for stronger pain medications. ^{1 2 3 6 7}

Who Is on the Research Team?

Phayvanh Pecha, MD

Principal Investigator

Medical University of South Carolina

Are You a Good Fit for This Trial?

This trial is for children aged 3-12 undergoing outpatient tonsillectomy, with or without adenoidectomy. It's not suitable for kids with bleeding disorders, recent steroid or opioid use, surgical complications, or if the guardian cannot be reached by phone.

Inclusion Criteria

I am between the ages of 3 and 12.

I have had my tonsils removed, with or without adenoid removal.

My surgery is scheduled and I will go home the same day.

Exclusion Criteria

I have used steroids for more than three days within a month before my tonsil surgery.

My parent/guardian cannot be reached by phone for follow-ups.

I have used opioids within 30 days before my tonsil surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Surgery and Initial Recovery

Participants undergo tonsillectomy and initial recovery, including randomization to receive either a steroid or placebo on the third post-operative day

3 days

1 visit (in-person for surgery)

Post-operative Monitoring

Participants' pain and medication use are monitored daily for 6 days post-surgery using a diary

6 days

Follow-up

Participants are monitored for complications such as oropharyngeal hemorrhage, emergency room visits, and readmissions within 30 days post-surgery

30 days

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The study tests whether a single oral dose of Dexamethasone can reduce pain and lessen the need for narcotic medications after tonsil surgery compared to a placebo.

How Is the Trial Designed?

Group I: Steroid Group Experimental Treatment 1 Intervention

Participants will receive a one-time dose of oral dexamethasone at 0.5 mg/kg on the third post-operative day

Group II: No Steroid Group Placebo Group 2 Interventions

Participants will receive placebo on third post-operative day

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

In a study of 60 patients undergoing tonsillectomy, a single dose of intravenous dexamethasone given during anesthesia significantly reduced postoperative pain scores at 6 and 12 hours compared to a control group without steroids.

No significant difference in pain was observed at 2 hours post-surgery, indicating that the pain relief effects of dexamethasone become more pronounced later in the recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of single dose perioperative intravenous steroid (dexamethasone) for postoperative pain relief in tonsillectomy patients. Buland, K., Zahoor, MU., Asghar, A., et al.[2013]

A single intraoperative dose of intravenous dexamethasone may slightly reduce pain after tonsillectomy, as indicated by a trend towards less pain reported in the first few days post-surgery among 34 patients.

The use of dexamethasone was associated with lower analgesic requirements in the recovery room, and importantly, it did not lead to any adverse effects, suggesting a favorable risk-benefit ratio for its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of steroids on posttonsillectomy pain in adults. Carr, MM., Williams, JG., Carmichael, L., et al.[2019]

A single preoperative dose of dexamethasone (0.5 mg/kg) significantly reduced the incidence of both early and late postoperative vomiting in children undergoing tonsillectomy, compared to a placebo.

Dexamethasone also decreased pain levels and the need for rescue antiemetics, leading to quicker oral intake and longer time before the first dose of analgesics was needed, indicating its efficacy in managing postoperative discomfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. Elhakim, M., Ali, NM., Rashed, I., et al.[2022]

A single dose of dexamethasone (0.5 mg/kg) given before pediatric tonsillectomy significantly reduced the incidence of vomiting and retching in the first 24 hours post-surgery, with rates of 37% in the dexamethasone group compared to 74% in the control group.

The study, involving 60 children aged 2-12 years, found that while dexamethasone was safe with no adverse effects, it did not significantly affect the need for rescue antiemetics, time to first oral intake, or analgesic requirements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of dexamethasone to reduce postoperative vomiting and pain after pediatric tonsillectomy procedures. Samarkandi, AH., Shaikh, MA., Ahmad, RA., et al.[2013]

In a study involving 62 children undergoing tonsillectomy, pre-incisional infiltration of dexamethasone did not significantly reduce postoperative pain, vomiting, or the need for additional pain relief compared to a placebo.

Despite previous findings suggesting dexamethasone's benefits in reducing postoperative symptoms, this study indicates that its use in this specific context may have limited effectiveness, warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-incisional infiltration of tonsils with dexamethasone dose not reduce posttonsillectomy vomiting and pain in children. Montazeri, K., Okhovat, A., Honarmand, A., et al.[2021]

In a study of 147 children aged 2-8 undergoing tonsillectomy, both doses of dexamethasone (0.15 mg/kg and 0.5 mg/kg) significantly reduced the incidence of early postoperative nausea and vomiting (PONV) compared to placebo (21% and 22% vs. 49%, respectively).

Dexamethasone also decreased severe pain on the second postoperative day, with only 5% of children in the 0.5 mg/kg group reporting severe pain compared to 47% in the placebo group, indicating its efficacy in managing postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. Hermans, V., De Pooter, F., De Groote, F., et al.[2018]

In a study of 58 children undergoing adenotonsillectomy, a single dose of dexamethasone significantly reduced postoperative vomiting from 48% to 4%.

Dexamethasone also decreased severe throat pain from 57% in the control group to 20% in the dexamethasone group, improving dietary tolerance on the first postoperative day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone in adenotonsillectomy. Tom, LW., Templeton, JJ., Thompson, ME., et al.[2019]

A single intravenous dose of dexamethasone given before tonsillectomy significantly reduced postoperative pain in patients, as shown by lower pain scores on the first, third, and fifth days after surgery (p-value < 0.001).

The study involved 100 patients aged 9-19 years undergoing cold dissection tonsillectomy, highlighting the efficacy of dexamethasone in improving recovery outcomes for this common surgical procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Preoperative Dexamethasone on Postoperative Pain in Patients Undergoing Tonsillectomy. Malhotra, V., Kumar, V.[2023]

A study involving 60 patients who underwent tonsillectomy showed that intravenous dexamethasone significantly reduced postoperative pain compared to a placebo, with pain levels measured over 5 days.

The results indicate that dexamethasone not only alleviates pain but also reduces odynophagia (painful swallowing) after surgery, making it an effective option for pain management in tonsillectomy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of dexamethasone on post tonsillectomy pain]. Ammar, G., Wang, Z.[2013]

In a study of 240 children undergoing tonsillectomy, local infiltration of dexamethasone significantly reduced postoperative pain and the time to first oral intake compared to intravenous administration.

While local infiltration was more effective for pain management, it was associated with a higher incidence of nausea and vomiting compared to the intravenous method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of local and intravenous dexamethasone for postoperative pain and recovery after tonsillectomy. Gao, W., Zhang, QR., Jiang, L., et al.[2015]

In a study involving 102 adults undergoing tonsillectomy, dexamethasone did not significantly reduce pain levels compared to a placebo, as measured on a visual analogue scale over 7 days.

There was also no significant difference in the consumption of narcotics between the dexamethasone and placebo groups, leading to the conclusion that dexamethasone is not recommended for routine use after tonsillectomy for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of dexamethasone to reduce pain after tonsillectomy in adults: a double-blind prospective randomized trial. Lachance, M., Lacroix, Y., Audet, N., et al.[2013]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6676167/

Systematic review of analgesics and dexamethasone for post ... Pooled estimates demonstrated that single-dose dexamethasone of 8 mg to 0.5 mg kg−1 decreased pain intensity equivalent to 23% at 4 h (−1.40 [95 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0007091219304040

Systematic review of analgesics and dexamethasone for ... Dexamethasone as a single intraoperative dose reduced pain within 4 h. When administered in multiple doses, the effect lasted beyond the first postoperative day ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6148143/

Steroid therapy for post-tonsillectomy symptoms in adults Patients treated with dexamethasone showed significantly less pain, nausea and vomiting, better healing and less granulation. There were no side effects ...

4. nature.com nature.com/articles/s41598-024-85008-5

Systematic review and meta-analysis of pain management ... Within the first 24 h and on day 3 after tonsillectomy, steroids significantly reduced patients' pain. This positive effect was also observed on ...

5. clinmedjournals.org clinmedjournals.org/articles/jor/journal-of-otolaryngology-and-rhinology-jor-10-148.php?jid=jor

Benifet of Dexamethasone in Post-Tonsillectomy Pain ... Conclusion: Dexamethasone locally injection was led to reducing post-tonsillectomy pain over a period of 9 days, especially on the third and sixth days.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8356107/

Pharmacologic management of post-tonsillectomy pain in ... Czarnetzki et al found an increase in bleeding risk after a single intraoperative dose of dexamethasone. However, that finding has not been ...

7. journals.lww.com journals.lww.com/md-journal/fulltext/2021/01150/dexamethasone_and_post_adenotonsillectomy_pain_in.66.aspx

Dexamethasone and post-adenotonsillectomy pain in ... In children undergoing adenotonsillectomy, dexamethasone decreased the early postoperative pain and PONV without increasing postoperative hemorrhage.