Steroids for Post-Tonsillectomy Pain
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Medical University of South Carolina
Must not be taking: Steroids, Opioids
Disqualifiers: Bleeding disorder, others
Prior Safety Data
Approved in 4 Jurisdictions
Trial Summary
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.
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.
12345Is 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.
36789How 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.
6781011Eligibility 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.
+3 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Steroid GroupExperimental Treatment1 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 GroupPlacebo Group2 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Medical University of South CarolinaCharleston, SC
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Who Is Running the Clinical Trial?
Medical University of South CarolinaLead Sponsor
References
Efficacy of single dose perioperative intravenous steroid (dexamethasone) for postoperative pain relief in tonsillectomy patients. [2013]To determine the efficacy of single dose perioperative intravenous steroid (dexamethasone) for postoperative pain relief in patients undergoing tonsillectomy.
[Effect of dexamethasone on post tonsillectomy pain]. [2013]To assess the effect of a course of intravenous dexamethasone on pain after tonsillectomy.
Effect of dexamethasone on nausea, vomiting, and pain in paediatric tonsillectomy. [2018]The efficacy of dexamethasone (DEX) to reduce morbidity after paediatric tonsillectomy remains controversial. We evaluated the effect of 0.15 and 0.5 mg kg(-1) DEX on the incidence of postoperative nausea and vomiting (PONV) and on pain intensity after paediatric tonsillectomy.
Effect of steroids on posttonsillectomy pain in adults. [2019]To determine whether a single intraoperative dose of intravenous dexamethasone has an effect on pain after tonsillectomy.
Comparison of local and intravenous dexamethasone for postoperative pain and recovery after tonsillectomy. [2015]To compare local infiltration of dexamethasone to intravenous injection for postoperative pain and recovery after tonsillectomy.
Pre-incisional infiltration of tonsils with dexamethasone dose not reduce posttonsillectomy vomiting and pain in children. [2021]Recently, dexamethasone has been found to have a prophylactic effect on postoperative vomiting and pain in children undergoing tonsillectomy. However, few studies have examined the preemptive analgesic effects of dexamethasone after tonsillectomy. The aim of this study was to evaluate the effect of pre-incisional infiltration of tonsils with dexamethasone on the incidence and severity of postoperative pain and vomiting in children undergoing tonsillectomy under general anesthesia.
Dexamethasone reduces postoperative vomiting and pain after pediatric tonsillectomy. [2022]Previous studies on dexamethasone's antiemetic and analgesic potential in children undergoing tonsillectomy have produced conflicting results. The aim of this study was to evaluate the effects of a single dose of dexamethasone on the incidence and severity of postoperative vomiting and pain in children undergoing electrocautery tonsillectomy under standardized general anesthesia.
Dexamethasone in adenotonsillectomy. [2019]Edema contributes substantially to the postoperative discomfort and morbidity of adenotonsillectomy. In a double-blind study, 58 children undergoing adenotonsillectomy were given a single intraoperative dose of either dexamethasone or saline. The steroid markedly affected the postoperative course in the first day after surgery. According to parental reports, the percentage of patients vomiting was reduced from 48 to 4%. Severe throat pain was reported in 57% of controls and only 20% of dexamethasone patients. Twice as many steroid patients as controls tolerated some soft food on the first postoperative day. It appears that dexamethasone can greatly improve patient diet and comfort after adenotonsillectomy.
Use of dexamethasone to reduce postoperative vomiting and pain after pediatric tonsillectomy procedures. [2013]The purpose of this study is to determine whether a single dose of dexamethasone 0.5mg/kg administered before surgery could decrease post operative vomiting and pain and improves oral intake in the first 24-hours after pediatric tonsillectomy procedures.
The use of dexamethasone to reduce pain after tonsillectomy in adults: a double-blind prospective randomized trial. [2013]To determine the effectiveness of dexamethasone to reduce pain after tonsillectomy in adults by at least 13 mm on the visual analogue scale. The secondary objective was to reduce the use of narcotics by at least 20%.
Effect of Preoperative Dexamethasone on Postoperative Pain in Patients Undergoing Tonsillectomy. [2023]Tonsillectomy is one of the most commonly performed surgical procedures worldwide. Postoperative pain remains a significant problem for patients undergoing tonsillectomy and is the most typical reason for readmission after the procedure. We conducted the present study to investigate the efficacy of a single dose of dexamethasone administered intravenously before tonsillectomy on postoperative pain in a group of patients undergoing cold dissection tonsillectomy, using a standardised anaesthetic and surgical procedure.It was a prospective study done in the Department of ENT in a tertiary care centre in eastern India, from 1 st September 2017 to 31 st August 2019 (2 years). Subjects included in the study were patients who attended the OPD of ENT of the tertiary care centre in eastern India, with a history of throat pain,difficulty in deglutition, mouth breathing, snoring. Tonsillectomy operation was recommended to the patients who fit the inclusion criteria. A hundred patients were selected for the study and divided randomly into two groups. Patients in group A (50 patients) were administered preoperative intravenous dexamethasone (0.15 mg/kg)after the induction of anaesthesia, and Group B patients (50 patients)were not administered dexamethasone along with other drugs.RESULTS: A hundred patients were enrolled after excluding the patients not fulfilling the selection criteria. The majority of patients were female, with the majority patients between 9-19 years. There was a noteworthy decreased mean pain score postoperatively of Group A on the first, third, and fifth day. (p-value = < 0.001).The results of this study suggest that a single preoperative injection of dexamethasone for patients undergoing tonsillectomy by cold dissection method significantly reduced postoperative pain.