Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 03/31/2016 |
| Primero enviado: | 03/31/2016 |
| Inscripción estimada enviada: | 04/18/2016 |
| Publicado por primera vez: | 04/21/2016 |
| Última actualización enviada: | 04/18/2016 |
| Última actualización publicada: | 04/21/2016 |
| Fecha de inicio real del estudio: | 03/31/2013 |
| Fecha estimada de finalización primaria: | 06/30/2015 |
| Fecha estimada de finalización del estudio: | 06/30/2015 |
Condición o enfermedad
Intervención / tratamiento
Drug: C group, (n=20)
Drug: TDN group, (n=20)
Drug: TDM group, (n=20)
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Placebo Comparator: C group, (n=20) C group (n=20) (placebo group) each patient received transdermal placebo patch, identical placebo patches custom-made by 1-800-Patches (Salt Lake City, UT) placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. | Drug: C group, (n=20) Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| Active Comparator: TDN group, (n=20) TDN group (n=20) each patient received transdermal therapeutic system- nicotine (15 mg/16 h),Nicorette® invisi 15mg patch releasing 15mg of nicotine over 16h, produced by Lohmann Therapie-System, Germany placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. | Drug: TDN group, (n=20) Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
| Active Comparator: TDM group, (n=20) TDM group (n=20) each patient received transdermal therapeutic system- melatonin (7 mg/8h),melatonin sleep patch from Respro Labs ™ containing 7 mg of melatonin placed 2 hours preoperatively for acute postoperative pain after laparoscopic cholecystectomy. | Drug: TDM group, (n=20) Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | Female |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - 60 female patients. - non-smoker patients. - aged between 18 and 50 years old. - ASA physical status I and II. - 70-90 kg body weight and height 160-180 cm. - undergoing elective laparoscopic cholecystectomy under general anesthesia. Exclusion Criteria: - Patients with impaired kidney or liver functions. - history of cardiac or central nervous system disease. - history of smoking. - history of drug or alcohol abuse. - history of chronic pain or daily intake of analgesics. - uncontrolled medical disease (diabetes mellitus and hypertension). - history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery. - allergy to the used medications. - coagulation defect. - local infection at the site of application of transdermal patch. - patient`s refusal. - duration of surgery more than 120 minutes. |
Salir
Medidas de resultado primarias
1. A mean difference of total analgesic (pethidine) consumption. [[Time Frame: The total pethidine requirements (mg) 12 hours postop]]
