Clinical trial NCT04879823: Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
Official title: Post-operative Course of Dexamethasone to Reduce Tonsillectomy Morbidity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Adenotonsillectomy
Analgesia
Surgery
Keywords: Pediatric Otolaryngology
Steroid
Placebo
Post-operative pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-05-10
Enrollment: 222
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind placebo controlled randomized clinical trial
Primary purpose: TREATMENT

Brief summary: The goal of this study is determine if an oral systemic course of steroids is a safe and effective option in lowering pain and complications following adenotonsillectomy in various pediatric age groups. A double blind, placebo-controlled randomized clinical trial of steroids (dexamethasone) versus placebo postoperatively will be performed. Investigators will determine if there is a difference in post-operative pain and complications between groups.

Detailed description: Purpose: To determine if post-operative dexamethasone is a safe and effective option in the reduction of post-operative pain and morbidity following adenotonsillectomy in various pediatric age groups.

Methods: The subject population will be patients between the ages of 3 and 17 who will undergo adenotonsillectomy. The study will consist of two double-blinded arms - patients receiving a course of oral dexamethasone (doses on post-operative days 2, 4, and 6; 0.5 mg/kg; max dose: 20 mg) in addition to standard pain control regimen and patients receiving an oral placebo course in addition to standard pain control regimen. In the diary they will receive, patients or caregivers will record when specific pain medications were taken each day, a symptoms survey, and pain ratings measured by the Wong-Baker FACES Pain Rating Scale. Patients are able to return their diary at a post-operative appointment at CHP Main, through email by scanning the diary or taking pictures with their phone, or through mailing in the survey in a pre-stamped envelope. Demographic information such as age, race, gender, and household income will be extracted from the diary and the electronic medical record. Information such as surgical technique, concurrent operations, post-operative pain prescription (types, weight based dosage, and total days prescribed) will be extracted from the electronic medical record and recorded as well. Outcomes measured will include pain scale rating and rates of complications between the two groups.

Significance: If it can be demonstrated that dexamethasone after adenotonsillectomy can reduce pain, complications, or need for opioid analgesics without appreciable side effects, a strong argument can be made for the addition of this inexpensive medication to routine post-operative adenotonsillectomy care. This would help with limiting the burden of clinical course of tonsillectomy.

The primary and secondary outcome measures were refined prior to analysis. Originally, the primary outcome measure was "average pain burden" defined as "average pain over 14 post-operative days before and after medications." However, study medication was not administered until day 2, and the power analysis was based on a study by Palme et al (2000) that compared mean pain ratings on postoperative days 2-8. Therefore, the primary outcome was revised to "average pain over 2-8 post-operative days before medications." Average pain over 2-8 post-operative after medications was added as a secondary outcome. The original primary outcome combined analysis of pain before and after medication into one measure. However, pain scores were more commonly reported prior to medication than after. Due to missing post-medication scores, it was determined that the analysis would be more appropriately conducted separately for pain scores before and after medication.

Eligibility criteria: Inclusion Criteria:

* Patients age 3 - 17 undergoing adenotonsillectomy meet inclusion criteria

Exclusion Criteria:

* Patients with Down syndrome
* Patients with a history of coagulopathy
* Patients with craniofacial abnormalities other than plagiocephaly or submucous cleft palate (SMCP)
* Caregivers who cannot speak, read, or write in English proficiently
* Patients who take systemic corticosteroids during the enrollment period
* Patients who take opioids during the enrollment period
* Patients who take chronic opioids
* Patients who are pregnant
* Patients with allergy to or contraindication for taking any of the study medications
* Patients who have the inability to communicate
* Patients who have the inability to localize pain
* Patients who have type 1 diabetes
* Patients who have type 2 diabetes

Primary outcomes:
measure: Average Pain Over 2-8 Post-operative Days Before Medications
timeFrame: 2-8 days post-operatively
Secondary outcomes:
measure: ED (Emergency Department) or Urgent Care Visits
timeFrame: 30 days post-operatively
measure: Average Pain Burden Post-medication
timeFrame: 2-8 days post-operatively
Other outcomes:
measure: Number of Readmissions
timeFrame: 30 days post-operatively
measure: Frequency of Each Analgesic Used
timeFrame: 14 days post-operatively
measure: Duration of Each Analgesic Used
timeFrame: 14 days post-operatively
measure: Pain Relief Satisfaction
timeFrame: 14 days post-operatively
measure: Frequency of Request for Opioid Medication
timeFrame: 14 days post-operatively
measure: Frequency of Post-operative Oropharyngeal Bleed
timeFrame: 30 days post-operatively
measure: Need for Follow-up Appointment
timeFrame: Two months post-operatively
measure: Household Income
timeFrame: 14 days post-operatively
measure: Education Level
timeFrame: 14 days post-operatively
measure: Side Effects of Medications
timeFrame: 14 days post-operatively
measure: Night-time Awakenings
timeFrame: 14 days post-operatively
measure: Post-operative Nursing Phone Calls
timeFrame: 30 days post-operatively
measure: Duration of Hospital Admission
timeFrame: 30 days post-operatively
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
city: Sewickley
country: United States
facility: Children's Hospital North Surgery Center
state: Pennsylvania
Study officials:
affiliation: Clinical Director, Division of Pediatric Otolaryngology, UPMC Children's Hospital of Pittsburgh
name: David H. Chi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.
citation: Whelan RL, McCoy J, Mirson L, Chi DH. Opioid prescription and postoperative outcomes in pediatric patients. Laryngoscope. 2019 Jun;129(6):1477-1481. doi: 10.1002/lary.27614. Epub 2018 Dec 26.
citation: Borgstrom A, Nerfeldt P, Friberg D. Postoperative pain and bleeding after adenotonsillectomy versus adenotonsillotomy in pediatric obstructive sleep apnea: an RCT. Eur Arch Otorhinolaryngol. 2019 Nov;276(11):3231-3238. doi: 10.1007/s00405-019-05571-w. Epub 2019 Aug 3.
citation: Titirungruang C, Seresirikachorn K, Kasemsuwan P, Hirunwiwatkul P. The use of steroids to reduce complications after tonsillectomy: a systematic review and meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2019 Feb;276(2):585-604. doi: 10.1007/s00405-018-5202-2. Epub 2018 Nov 17.
citation: Macassey E, Dawes P, Taylor B, Gray A. The effect of a postoperative course of oral prednisone on postoperative morbidity following childhood tonsillectomy. Otolaryngol Head Neck Surg. 2012 Sep;147(3):551-6. doi: 10.1177/0194599812447776. Epub 2012 May 14.
citation: Redmann AJ, Maksimoski M, Brumbaugh C, Ishman SL. The effect of postoperative steroids on post-tonsillectomy pain and need for postoperative physician contact. Laryngoscope. 2018 Sep;128(9):2187-2192. doi: 10.1002/lary.27167. Epub 2018 Mar 24.
citation: Greenwell AG, Isaiah A, Pereira KD. Recovery After Adenotonsillectomy-Do Steroids Help? Outcomes From a Randomized Controlled Trial. Otolaryngol Head Neck Surg. 2021 Jul;165(1):83-88. doi: 10.1177/0194599820973250. Epub 2020 Nov 24.
citation: Garra G, Singer AJ, Taira BR, Chohan J, Cardoz H, Chisena E, Thode HC Jr. Validation of the Wong-Baker FACES Pain Rating Scale in pediatric emergency department patients. Acad Emerg Med. 2010 Jan;17(1):50-4. doi: 10.1111/j.1553-2712.2009.00620.x. Epub 2009 Dec 9.
citation: Palme CE, Tomasevic P, Pohl DV. Evaluating the effects of oral prednisolone on recovery after tonsillectomy: a prospective, double-blind, randomized trial. Laryngoscope. 2000 Dec;110(12):2000-4. doi: 10.1097/00005537-200012000-00003.
citation: Feinberg AE, Chesney TR, Srikandarajah S, Acuna SA, McLeod RS; Best Practice in Surgery Group. Opioid Use After Discharge in Postoperative Patients: A Systematic Review. Ann Surg. 2018 Jun;267(6):1056-1062. doi: 10.1097/SLA.0000000000002591.
citation: Monitto CL, Hsu A, Gao S, Vozzo PT, Park PS, Roter D, Yenokyan G, White ED, Kattail D, Edgeworth AE, Vasquenza KJ, Atwater SE, Shay JE, George JA, Vickers BA, Kost-Byerly S, Lee BH, Yaster M. Opioid Prescribing for the Treatment of Acute Pain in Children on Hospital Discharge. Anesth Analg. 2017 Dec;125(6):2113-2122. doi: 10.1213/ANE.0000000000002586.