Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05695664
Status:
COMPLETED
Last Update Posted:
2023-01-25
First Post:
2023-01-12
Brief Title:
Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing in Orthopedic Surgery
Sponsor:
Benazir Bhutto Hospital Rawalpindi
Organization:
Benazir Bhutto Hospital Rawalpindi
Study Overview
Official Title:
Comparison of the Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing Orthopedic Surgery
Status:
COMPLETED
Status Verified Date:
2023-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objectives To compare the postoperative analgesic effects of ibuprofen versus ketorolac in patients undergoing orthopedic surgery at Combined Military Hospital Rawalpindi
Study design Randomized controlled trial Setting Department of Anasthesiology Combined military Hospital Rawalpindi Duration of study6 months 01st August 2021 to 31st January 2022 Material and methods After ethical approval 100 patients in randomly divided two equal groups A and B were selected In group A 800 mg IV ibuprofen while in group B 30 mg IV ketorolac was given within 30 min of skin closure after orthopedic surgery The pain was assessed via visual analogue scale postoperatively The SPSS version 25 was used for analysis of data P value 005 was considered as significant
Study design Randomized controlled trial Setting Department of Anasthesiology Combined military Hospital Rawalpindi Duration of study6 months 01st August 2021 to 31st January 2022 Material and methods After ethical approval 100 patients in randomly divided two equal groups A and B were selected In group A 800 mg IV ibuprofen while in group B 30 mg IV ketorolac was given within 30 min of skin closure after orthopedic surgery The pain was assessed via visual analogue scale postoperatively The SPSS version 25 was used for analysis of data P value 005 was considered as significant
Detailed Description:
INTRODUCTION Healthcare seeks to decrease postoperative pain to ensure better and faster postoperative mobilization1 Postoperative pain pathways identify populations at risk for 30-day readmissions and emergency department visits that are not due to post discharge complications2 Chronic pain is acknowledged as a disease per se and addressing pain control expectations before discharge could reduce surgical readmissions3 However despite advances in perioperative protocols pain remains a very frequent clinical symptom seen by orthopedic surgeons and a major reason for patients to seek medical assistance Moreover pain management after orthopedic procedures remains suboptimal for many patients4 For instance 37 of orthopedic patients reported their pain to be severe at its highest intensity where postoperative pain remains a problem that requires consensus and joint efforts5 Several modalities are available to alleviate the postoperative period which range from nerve blocks to the use of various classes of drugs Opioids have been widely used for pain relief However this class of drug is associated with a wide range of side effects including a potential for developing drug dependence and addiction On the other hand non-steroidal anti-inflammatory drugs NSAIDs have been used widely for pain relief NSAIDs are widely available as compared to opioids NSAIDs also have several side effects but a study has proven NSAIDs to be safe for controlling acute postoperative pain if they are used appropriately6 Several studies have compared the different drugs belonging to the NSAID class in terms of their efficacy as postoperative analgesia A study found no difference in pain and satisfaction between two groups of patients receiving either IV ketorolac or IV Ibuprofen as part of postoperative analgesia following urogynecological surgeries7 However patients who underwent laparotomies had less pain with Keterolac8 In another study carried out on patients undergoing knee arthroscopies preemptive use of Ibuprofen 800 mg was associated with less postoperative pain9 Uribe et al compared the postoperative analgesic effects of ibuprofen and ketorolac and discovered a difference in rescue analgesic use 55 vs 839 time to first rescue analgesic use 7762 3303 vs 5578 3537 hours and analgesic requirement in PACU 553 589 vs 1992 1563 mg p value 00510 Postoperative pain is one of the principal concerns of surgeons and anesthesiologists which leads to prolonged hospitalization and an increased analgesic requirement Both factors expose the patient to hospital acquired infection and the untoward side effects of analgesics As a result a balanced or multimodal analgesia with adjuvant medications is required It is important that as anesthesiologists we understand the effective method for pain suppression during orthopedic procedures Therefore this study is aimed at filling this knowledge gap Data from this study would add information and serve as a baseline for the development of management guidelines for pain management
METHODS AND MATERIALS After obtaining approval from the Ethical Committee Institutional Review Board IRB document no 1560521 patients undergoing orthopedic surgeries were enrolled in the Department of Anesthesiology and Orthopedics at the Combined Military Hospital Rawalpindi The sample size for this randomized controlled trial RCT was 100 patients 50 patients in each group which was calculated from a previous study by taking the frequencies of rescue analgesic use as 55 vs 839 11 The power of the test was 90 with a 5 level of significance The research lasted six months from August 1 2021 to January 31 2022 All patients gave their informed written consent The patients of either gender with an age range of 40-80 years and an ASA grade of 2 who were undergoing orthopedic surgeries for fractures of the radius ulna and wrist were included in the study Patients with a history of adverse reactions to ibuprofen or ketorolac a history of epilepsy bronchial asthma coronary artery disease renal or hepatic impairments or use of antiarrhythmic or analgesic medications in the last seven days were excluded Age gender obesity BMI 27 kgm2 history of smoking 10 or more cigarettes per day for at least 5 years or 5 or more cigarettes per day for at least 10 years diabetes and hypertension were registered before pre-operative evaluation of the patients to assess their fitness for anesthesia The patients were labeled as diabetics when they were on anti-diabetic medication for at least 6 months or when there was lab evidence of HBA1c 65 fasting blood sugar of 126 mgdL or a random blood sugar level of 200 mgdL Patients were classified as hypertensive if they had been taking anti-hypertensive medication for at least 6 months or if clinical evidence of blood pressure greater than 14090 was found on at least two separate occasions at least two hours apart All patients were randomly divided into two equal groups A and B by using the sealed envelope technique All surgeries were done under standard general anesthesia Patients were induced with propofol 2 mgkg and premedicated with fentanyl Endotracheal intubation was facilitated by the muscle relaxant atracurium 05 mgkg Anesthesia was maintained with 50 O2 50 air 1 MAC isoflurane and atracurium The patients were mechanically ventilated to keep ETCO2 between 35 and 40 mmHg In Group A patients received an intravenous injection of 800 mg of Ibuprofen while intravenous ketorolac 30 mg was given to patients in Group B approximately 30 minutes before the skin closure All patients were extubated and transferred to the post-anesthesia care unit PACU The durations of the surgical procedure and anesthesia were documented Another anesthesiologist on duty was deputed for follow-up with the patients The patients were kept blind to the type of analgesic drug they received The postoperative pain was measured by VAS at 3 6 and 12 hours postoperatively The VAS ranged from 0 to 10 with 0 representing no pain and 10 representing the maximum bearable pain When the VAS score was 4 the injection Tramadol 30 mg was given intravenously as a rescue analgesic The frequency of patients requiring rescue analgesia the time to start rescue analgesia and the total dose of drug during the 12-hour postoperative period were noted in each group
Statistical analysis The data was analyzed by IBM SPSS Version 20 registered for Microsoft Windows The mean standard deviation and frequencypercentages were calculated for quantitative and qualitative data respectively Chi square and independent sample t-tests were used to compare postoperative analgesic parameters between both groups The p value of 005 was taken as statistically significant
METHODS AND MATERIALS After obtaining approval from the Ethical Committee Institutional Review Board IRB document no 1560521 patients undergoing orthopedic surgeries were enrolled in the Department of Anesthesiology and Orthopedics at the Combined Military Hospital Rawalpindi The sample size for this randomized controlled trial RCT was 100 patients 50 patients in each group which was calculated from a previous study by taking the frequencies of rescue analgesic use as 55 vs 839 11 The power of the test was 90 with a 5 level of significance The research lasted six months from August 1 2021 to January 31 2022 All patients gave their informed written consent The patients of either gender with an age range of 40-80 years and an ASA grade of 2 who were undergoing orthopedic surgeries for fractures of the radius ulna and wrist were included in the study Patients with a history of adverse reactions to ibuprofen or ketorolac a history of epilepsy bronchial asthma coronary artery disease renal or hepatic impairments or use of antiarrhythmic or analgesic medications in the last seven days were excluded Age gender obesity BMI 27 kgm2 history of smoking 10 or more cigarettes per day for at least 5 years or 5 or more cigarettes per day for at least 10 years diabetes and hypertension were registered before pre-operative evaluation of the patients to assess their fitness for anesthesia The patients were labeled as diabetics when they were on anti-diabetic medication for at least 6 months or when there was lab evidence of HBA1c 65 fasting blood sugar of 126 mgdL or a random blood sugar level of 200 mgdL Patients were classified as hypertensive if they had been taking anti-hypertensive medication for at least 6 months or if clinical evidence of blood pressure greater than 14090 was found on at least two separate occasions at least two hours apart All patients were randomly divided into two equal groups A and B by using the sealed envelope technique All surgeries were done under standard general anesthesia Patients were induced with propofol 2 mgkg and premedicated with fentanyl Endotracheal intubation was facilitated by the muscle relaxant atracurium 05 mgkg Anesthesia was maintained with 50 O2 50 air 1 MAC isoflurane and atracurium The patients were mechanically ventilated to keep ETCO2 between 35 and 40 mmHg In Group A patients received an intravenous injection of 800 mg of Ibuprofen while intravenous ketorolac 30 mg was given to patients in Group B approximately 30 minutes before the skin closure All patients were extubated and transferred to the post-anesthesia care unit PACU The durations of the surgical procedure and anesthesia were documented Another anesthesiologist on duty was deputed for follow-up with the patients The patients were kept blind to the type of analgesic drug they received The postoperative pain was measured by VAS at 3 6 and 12 hours postoperatively The VAS ranged from 0 to 10 with 0 representing no pain and 10 representing the maximum bearable pain When the VAS score was 4 the injection Tramadol 30 mg was given intravenously as a rescue analgesic The frequency of patients requiring rescue analgesia the time to start rescue analgesia and the total dose of drug during the 12-hour postoperative period were noted in each group
Statistical analysis The data was analyzed by IBM SPSS Version 20 registered for Microsoft Windows The mean standard deviation and frequencypercentages were calculated for quantitative and qualitative data respectively Chi square and independent sample t-tests were used to compare postoperative analgesic parameters between both groups The p value of 005 was taken as statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None