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Post-tonsillectomy Pain Control in Adults

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Patrocinadores
University of Nebraska

Palavras-chave

Resumo

This is a randomized prospective study to determine the optimal postoperative pain medication regimen for adults (18 years old and older) undergoing tonsillectomy with or without adenoidectomy for chronic tonsillitis and/or snoring and/or obstructive sleep apnea. All participants will undergo the same tonsillectomy surgical technique (with or without adenoidectomy) under general anesthesia and be randomized to one of three postoperative pain control regimens (all of which are commonly used pain medications for post-tonsillectomy pain):
1. Norco (Hydrocodone and Acetaminophen)
2. Percocet (Oxycodone and Acetaminophen)
3. Dilaudid and Tylenol (Acetaminophen)
Participants will be discharged home the day of surgery and will be sent home with questionnaires to assess their daily pain level, oral intake, amount of nausea/vomiting, and amount of pain medications taken for the 14 days following their surgery. Data will be collected and analyzed to determine if there is a difference in pain levels or oral intake or nausea/vomiting in the different pain regimen groups. Secondary endpoints will include weight change from preoperative weight to weight at 2-3 weeks after surgery in addition to postoperative complications including visits to the Emergency Department and post-tonsillectomy bleed rates.
Participants will be seen 1-2 weeks following their surgery in the ENT (Ear, Nose and Throat) clinic per normal postoperative protocol and will not require any specific clinic visits related to this study.

Descrição

Hypotheses

- There is an optimal pain control regimen for post-tonsillectomy pain control in adults

- Post-tonsillectomy pain levels in adults peak around postoperative day number seven

- Post-tonsillectomy adults return very slowly to normal (pre-surgery) oral intake and diet

Purpose

- To assess daily post-tonsillectomy pain level in adults for the two weeks after surgery

- To determine if there is an optimal post-tonsillectomy pain control regimen in adults for the two weeks after surgery

- To determine oral intake levels in post-tonsillectomy adults for the two weeks after surgery

- To determine daily amounts of nausea/vomiting in post-tonsillectomy adults for the two weeks after surgery

- To determine the change in weight in the two to three weeks after surgery

Study Background Tonsillectomy (with or without adenoidectomy) is a very common procedure in children and adults. The most common indications for tonsillectomies include chronic tonsillitis and/or obstructive sleep apnea. While many studies have examined the optimal postoperative pain control regimen in children, the optimal pain control regimen in adults remains poorly studied and understood.

Literature regarding post-tonsillectomy pain in adults has primarily focused on the specific tonsillectomy surgical technique (there are many) rather than the exact medications used for pain control. Interestingly, some of these aforementioned studies did not include the name, type or quantity of pain medications given to their patients when the primary study endpoint was pain. Additional studies have examined the role of steroids, antibiotics, and/or pain medications given by Anesthesia while a patient is anesthetized and undergoing tonsillectomy to determine if this can reduce postoperative pain. IV steroids given perioperatively to adults undergoing tonsillectomy have less pain, nausea, and vomiting in the first few days after tonsillectomy. IV steroids are now routinely given before tonsillectomy by most practicing Otolaryngologists, including our senior authors.

There are a limited number of studies looking at actual postoperative pain control regimens in adults. Most of these studies are limited in that they only looked at the first 24 hours following surgery rather than trending pain levels for the first week or two after surgery. Additional studies are limited because they are observational or prospective without comparative pain regimen groups (i.e. they gave all patients the same medications asked them their daily pain levels).

Furthermore, a majority of studies involving postoperative pain control used a "cold steel" technique tonsillectomy, which is uncommonly practiced in the United States by Otolaryngologists, who prefer the use of electrocautery devices for tonsillectomy. It is well known and accepted that cautery causes more postoperative pain due to thermal tissue injury, however it allows for a straightforward surgery with better intraoperative control of bleeding. Furthermore, randomized prospective studies for postoperative pain control following cautery tonsillectomy are lacking in the literature.

It is well known that the expected recovery period for adults is 2-4 weeks, during which they cannot work or do any strenuous activity. We would argue that the first 24 hours after tonsillectomy is actually better tolerated by adults because they have received high potency narcotics (usually through their IV) during and right after surgery. Therefore a more meaningful time period to study would be postoperative day number 1 - 14, when the patient is at home and the pain is most severe (most patients state that their pain peaks around postoperative number 5-7). Pain control is incredibly important issue in the post-tonsillectomy patient. If they have too much pain, they will not drink or eat enough to stay hydrated and nourished. This can lead to electrolyte abnormalities and dehydration requiring visits to the Emergency Department with or without admission to the hospital.

The purpose of this study is to evaluate post-tonsillectomy pain control in adults using three randomized medication regimens. All patients would undergo the same surgical technique to avoid confounding variables. Surgeries would be performed by Otolaryngology - Head and Neck Surgery Residents under the direct supervision of Otolaryngology staff attending surgeons. All of the proposed pain regimens are commonly accepted regimens used by practicing Otolaryngologists for adults.

Patients would be asked to complete a questionnaire that numerically evaluates their daily: pain level, amount of oral intake, amount of nausea/vomiting, and amount of pain medications used. They would asked to mail in their results or return the clinic. Additional information would be collected from the patients and/or their medical records including visits to the emergency department, readmissions to the hospital, and postoperative complications including post-tonsillectomy bleeding. Data would be compiled and analyzed to determine the typical postoperative pain levels, daily oral intake level, and to compare the different pain regimens to determine if one is superior.

It is important to note that there are accepted risks of general anesthesia and undergoing tonsillectomy with or without adenoidectomy. Participation in this study would not change any of the accepted risk of undergoing the surgical procedure. The risks commonly discussed with patients before tonsillectomy with or without adenoidectomy include failure to resolve chronic throat infections, failure to resolve obstructive sleep apnea, voice changes after surgery, damage to lips/teeth/tongue, taste changes, dehydration, need to return to the emergency department, need for admission to the hospital, and 3-5% risk of post-tonsillectomy bleeding that may result in need for additional surgical procedures and/or blood transfusions.

datas

Última verificação: 09/30/2017
Enviado pela primeira vez: 01/13/2015
Inscrição estimada enviada: 02/02/2015
Postado pela primeira vez: 02/08/2015
Última atualização enviada: 10/17/2017
Última atualização postada: 10/19/2017
Data real de início do estudo: 12/31/2015
Data Estimada de Conclusão Primária: 05/31/2019

Condição ou doença

Pain, Postoperative
Postoperative Nausea and Vomiting
Postoperative Hemorrhage
Body Weight Changes

Intervenção / tratamento

Drug: Tonsillectomy and Norco

Drug: Tonsillectomy and Percocet

Drug: Tonsillectomy and Dilaudid + Tylenol

Drug: Tonsillectomy and Dilaudid + Tylenol

Fase

Fase 4

Grupos de Armas

BraçoIntervenção / tratamento
Active Comparator: Tonsillectomy and Norco
This represents patients who will be randomized (1:3 chance) to postoperative pain control with Norco (Hydrocodone and Acetaminophen)
Drug: Tonsillectomy and Norco
Norco (Hydrocodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN (as needed) pain following Tonsillectomy for 14 days
Active Comparator: Tonsillectomy and Percocet
This represents patients who will be randomized (1:3 chance) to postoperative pain control with Percocet (Oxycodone and Acetaminophen)
Drug: Tonsillectomy and Percocet
Percocet (Oxycodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days
Active Comparator: Tonsillectomy and Dilaudid + Tylenol
This represents patients who will be randomized (1:3 chance) to postoperative pain control with Dilaudid (hydromorphone) and Tylenol (Acetaminophen)
Drug: Tonsillectomy and Dilaudid + Tylenol
Dilaudid (hydromorphone) 2 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days

Critério de eleição

Idades qualificadas para estudar 18 Years Para 18 Years
Sexos elegíveis para estudoAll
Aceita Voluntários Saudáveissim
Critério

Inclusion Criteria:

- 18 years and older

- Surgical indications: Chronic tonsillitis, Snoring, Sleep apnea

- Surgical procedure: Tonsillectomy with monopolar cautery, hemostasis with monopolar cautery and/or suction cautery. The surgical procedure can also include Adenoidectomy with suction cautery

Exclusion Criteria:

- Additional surgical procedures (i.e. UPPP (uvulopalatopharyngoplasty), septoplasty, inferior turbinate reduction) during same surgery

- Pregnant females

- Indications: Suspected malignancy

- History of chronic pain or daily pain medication used for another medical problem

- History of liver disease

- Contraindications to preoperative Decadron

- Contraindications to pain regimen medications (Tylenol, Norco, Percocet, Dilaudid)

Resultado

Medidas de Resultado Primário

1. Daily pain level [Postoperative day 1]

Daily pain level on scale from 0-10

2. Daily pain level [Postoperative day 2]

Daily pain level on scale from 0-10

3. Daily pain level [Postoperative day 3]

Daily pain level on scale from 0-10

4. Daily pain level [Postoperative day 4]

Daily pain level on scale from 0-10

5. Daily pain level [Postoperative day 5]

Daily pain level on scale from 0-10

6. Daily pain level [Postoperative day 6]

Daily pain level on scale from 0-10

7. Daily pain level [Postoperative day 7]

Daily pain level on scale from 0-10

8. Daily pain level [Postoperative day 8]

Daily pain level on scale from 0-10

9. Daily pain level [Postoperative day 9]

Daily pain level on scale from 0-10

10. Daily pain level [Postoperative day 10]

Daily pain level on scale from 0-10

11. Daily pain level [Postoperative day 11]

Daily pain level on scale from 0-10

12. Daily pain level [Postoperative day 12]

Daily pain level on scale from 0-10

13. Daily pain level [Postoperative day 13]

Daily pain level on scale from 0-10

14. Daily pain level [Postoperative day 14]

Daily pain level on scale from 0-10

Medidas de Resultado Secundário

1. Daily oral liquid intake [Postoperative day 1]

Daily estimation of cups of liquids consumed

2. Daily oral liquid intake [Postoperative day 2]

Daily estimation of cups of liquids consumed

3. Daily oral liquid intake [Postoperative day 3]

Daily estimation of cups of liquids consumed

4. Daily oral liquid intake [Postoperative day 4]

Daily estimation of cups of liquids consumed

5. Daily oral liquid intake [Postoperative day 5]

Daily estimation of cups of liquids consumed

6. Daily oral liquid intake [Postoperative day 6]

Daily estimation of cups of liquids consumed

7. Daily oral liquid intake [Postoperative day 7]

Daily estimation of cups of liquids consumed

8. Daily oral liquid intake [Postoperative day 8]

Daily estimation of cups of liquids consumed

9. Daily oral liquid intake [Postoperative day 9]

Daily estimation of cups of liquids consumed

10. Daily oral liquid intake [Postoperative day 10]

Daily estimation of cups of liquids consumed

11. Daily oral liquid intake [Postoperative day 11]

Daily estimation of cups of liquids consumed

12. Daily oral liquid intake [Postoperative day 12]

Daily estimation of cups of liquids consumed

13. Daily oral liquid intake [Postoperative day 13]

Daily estimation of cups of liquids consumed

14. Daily oral liquid intake [Postoperative day 14]

Daily estimation of cups of liquids consumed

15. Daily nausea/vomiting [Postoperative day 1]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

16. Daily nausea/vomiting [Postoperative day 2]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

17. Daily nausea/vomiting [Postoperative day 3]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

18. Daily nausea/vomiting [Postoperative day 4]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

19. Daily nausea/vomiting [Postoperative day 5]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

20. Daily nausea/vomiting [Postoperative day 6]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

21. Daily nausea/vomiting [Postoperative day 7]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

22. Daily nausea/vomiting [Postoperative day 8]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

23. Daily nausea/vomiting [Postoperative day 9]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

24. Daily nausea/vomiting [Postoperative day 10]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

25. Daily nausea/vomiting [Postoperative day 11]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

26. Daily nausea/vomiting [Postoperative day 12]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

27. Daily nausea/vomiting [Postoperative day 13]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

28. Daily nausea/vomiting [Postoperative day 14]

Daily amount of nausea/vomiting with a scale from 0 - 4. 0 = no nausea = mild nausea = significant nausea and/or dry heaving = vomiting

29. Weight Change from Baseline [Preoperative weight compared to postoperative weight at 2-3 weeks after surgery]

Weight change comparing preoperative weight (kg) to postoperative weight (kg) at 2-3 weeks after surgery

30. Visit to emergency department after surgery [Within 14 days after surgery]

Yes/No answer for if patient needed to visit the emergency department after surgery for any reason related to their surgery

31. Post tonsillectomy hemorrhage [Within 14 days after surgery]

If patient had a post tonsillectomy hemorrhage and if any treatment was needed

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