Preoperative Acetaminophen and Carbohydrate Loading
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StatusLengkap
Sponsor
Tufts Medical Center
UJI KLINIS: NCT03131713
BioSeek: NCT03131713
Kata kunci
Abstrak
The study's goal is to assess impact of preoperative acetaminophen and oral carbohydrate drinks on pain and functional status experienced by patients undergoing Mohs micrographic surgery for non-melanoma skin cancers. Patients are randomly assigned to receive standard of care or preoperative acetaminophen 1000 mg and Gatorade sports drinks 2 packets before surgery. Patients are then asked to rate their level of pain, anxiety, thirst, hunger, fatigue on a scale of 0-100 on day of surgery before surgery has started, after clearance of skin cancer, and at the end of the visit. Patients are contacted by phone 48 hours after their surgery to assess their maximum level of post-operative pain (rated from 0-100), usage of over the counter or prescribed pain medications, and presence of complications e.g. bleeding, infection, dehiscence. Differences in perioperative functional status and pain medication usage are compared between patients in control and intervention groups.
tanggal
| Terakhir Diverifikasi: | 09/30/2019 |
| Pertama Dikirim: | 03/05/2017 |
| Perkiraan Pendaftaran Telah Dikirim: | 04/25/2017 |
| Pertama Diposting: | 04/26/2017 |
| Pembaruan Terakhir Dikirim: | 10/03/2019 |
| Pembaruan Terakhir Diposting: | 10/06/2019 |
| Tanggal hasil pengiriman pertama: | 07/11/2019 |
| Tanggal hasil QC pertama kali dikirim: | 10/03/2019 |
| Tanggal hasil posting pertama: | 10/06/2019 |
| Tanggal Mulai Studi Sebenarnya: | 06/30/2016 |
| Perkiraan Tanggal Penyelesaian Utama: | 12/30/2017 |
| Perkiraan Tanggal Penyelesaian Studi: | 12/30/2017 |
Kondisi atau penyakit
Non-melanoma Skin Cancer
Intervensi / pengobatan
Drug: Intervention
Tahap
Tahap 3
Kelompok Lengan
| Lengan | Intervensi / pengobatan |
|---|---|
| No Intervention: Control The control group will receive usual perioperative care including patient education on diagnosis, treatment and prognosis of skin cancer, encouragement of food and fluid intake prior to and during the surgery as needed, and acetaminophen per patient request. | |
| Experimental: Intervention The intervention group, in addition to usual care, will receive Acetaminophen 1000mg and commercially available carbohydrate drink (two pouches of Gatorade Prime Sports Fuel drink containing 50gm carbohydrate in approximately 250ml fluid total) at the beginning of the surgery. | Drug: Intervention Acetaminophen 1000mg |
Kriteria kelayakan
| Usia yang Layak untuk Belajar | 18 Years Untuk 18 Years |
| Jenis Kelamin yang Layak untuk Belajar | All |
| Menerima Relawan Sehat | Iya |
| Kriteria | Inclusion Criteria: - Adult patients undergoing Mohs micrographic surgery for non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma) Exclusion Criteria: - history of liver transplant, hepatitis, or cirrhosis, those required to be NPO for subsequent closure by other surgical specialties, or those with known allergy to acetaminophen |
Hasil
Ukuran Hasil Utama
1. Maximum Pain Score [Day of surgery]
Rated on a pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
Ukuran Hasil Sekunder
1. Thirst [Day of surgery]
Rated on a thirst scale of 0-100. Higher score means worse outcome; lower score means better outcome.
2. Hunger [Day of surgery]
Rated on a hunger scale of 0-100. Higher score means worse outcome; lower score means better outcome.
3. Anxiety [Day of surgery]
Rated on n anxiety scale of 0-100. Higher score means worse outcome; lower score means better outcome.
4. Fatigue [Day of surgery]
Rated on a fatigue scale of 0-100. Higher score means worse outcome; lower score means better outcome.
5. Number of Participants Using Post-operative Analgesic [48 hours after surgery]
Number of participants using over the counter and prescribed non-opioid and opioid pain medications
6. Maximum Post-op Pain Score [48 hours after surgery]
Rated on a maximum post-op pain scale of 0-100. Higher score means worse outcome; lower score means better outcome.
