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

Trial Summary

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.

What data supports the effectiveness of the drug Dexamethasone for post-tonsillectomy pain relief?

Research shows that a single dose of dexamethasone given during surgery can help reduce pain after a tonsillectomy. It has also been found to potentially decrease nausea and vomiting in children after the procedure. ^{1 2 3 4 5}

Is dexamethasone safe for use in children undergoing tonsillectomy?

Dexamethasone has been studied in children undergoing tonsillectomy and is generally considered safe, as it can reduce vomiting and pain after surgery. It has been shown to improve comfort and allow better food intake shortly after the procedure. ^{3 6 7 8 9}

How does the drug dexamethasone help with post-tonsillectomy pain?

Dexamethasone is unique because it can significantly reduce pain and the need for narcotics after a tonsillectomy by being administered as a single preoperative dose. This steroid also helps decrease swelling and vomiting, improving comfort and allowing patients to eat soft foods sooner after surgery. ^{6 7 8 10 11}

What is the purpose of this trial?

This trial is testing if an oral steroid called dexamethasone can reduce pain and the need for narcotic painkillers in children after tonsil removal surgery. Dexamethasone helps by reducing inflammation and swelling, which can make recovery less painful. It has been shown to be effective in reducing postoperative pain, swelling, and other complications in various surgeries, including third molar extractions and rhinoplasty.

Research Team

Phayvanh Pecha, MD

Principal Investigator

Medical University of South Carolina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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 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]

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]

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 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 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]

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]

References

1. Pakistan pubmed.ncbi.nlm.nih.gov

Efficacy of single dose perioperative intravenous steroid (dexamethasone) for postoperative pain relief in tonsillectomy patients. [2013]

2. China pubmed.ncbi.nlm.nih.gov

[Effect of dexamethasone on post tonsillectomy pain]. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. [2018]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of steroids on posttonsillectomy pain in adults. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Comparison of local and intravenous dexamethasone for postoperative pain and recovery after tonsillectomy. [2015]

6. India pubmed.ncbi.nlm.nih.gov

Pre-incisional infiltration of tonsils with dexamethasone dose not reduce posttonsillectomy vomiting and pain in children. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Dexamethasone in adenotonsillectomy. [2019]

9. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Use of dexamethasone to reduce postoperative vomiting and pain after pediatric tonsillectomy procedures. [2013]

10. United States pubmed.ncbi.nlm.nih.gov

The use of dexamethasone to reduce pain after tonsillectomy in adults: a double-blind prospective randomized trial. [2013]

11. India pubmed.ncbi.nlm.nih.gov

Effect of Preoperative Dexamethasone on Postoperative Pain in Patients Undergoing Tonsillectomy. [2023]