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AzTrials

Intravenous Drug UsageEarly Phase 1NCT05695664

Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing in Orthopedic Surgery

A Early Phase 1 study testing Ibuprofen 800 mg and Ketorolac Injection in people with Intravenous Drug Usage and Ibuprofen, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 study:6… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Intravenous Drug Usage, Ibuprofen, Ketorolac
What is being tested?
Ibuprofen 800 mg and Ketorolac Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 sitePakistan
Study dates
1 Aug 2021to 31 Jan 2022
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of either gender undergo orthopedic surgery were included in the study.
  • ASA ≤ 2
  • Age 40-80 years.
  • Fracture Radius , Ulna, and wrist

Who cannot join

  • Patients with history of adverse response from ketorolac and ibuprofen was not taken into the study.
  • Patients with history of epilepsy.
  • Patients with history of cardiac conduction defects.
  • Patients on antiarrhythmic drugs or analgesics.
  • Patients with H/O stroke, renal impairment, chronic obstructive pulmonary disease, asthma, chronic liver disease, hypothyroidism and CCF were excluded.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Fazal Hussain

    Bhakkar, Punjab Province, 300000

Other trials in Pakistan

About this study

Official title: Comparison of the Postoperative Analgesic Effects of Ibuprofen Versus Ketorolac in Patients Undergoing Orthopedic Surgery

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 study:6 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 ≤ 0.05 was considered as significant.

Read the detailed description

INTRODUCTION Healthcare seeks to decrease postoperative pain to ensure better and faster postoperative mobilization.1 Postoperative pain pathways identify populations at risk for 30-day readmissions and emergency department visits that are not due to post discharge complications.2 Chronic pain is acknowledged as a disease per se, and addressing pain control expectations before discharge could reduce surgical readmissions.3 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 patients.4 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 efforts.5 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 appropriately.6 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 surgeries.7 However, patients who underwent laparotomies had less pain with Keterolac.8 In another study carried out on patients undergoing knee arthroscopies, preemptive use of Ibuprofen 800 mg was associated with less postoperative pain.9 Uribe et al. compared the postoperative analgesic effects of ibuprofen and ketorolac and discovered a difference in rescue analgesic use (55% vs. 83.9%), time to first rescue analgesic use (77.62 ± 33.03 vs. 55.78 ± 35.37 hours), and analgesic requirement in PACU (5.53 ± 5.89 vs. 19.92 ± 15.63 mg, p value 0.05).10 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. 156/05/21), 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. 83.9%). 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 kg/m2), 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 >6.5%, fasting blood sugar of >126 mg/dL, or a random blood sugar level of >200 mg/dL. 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 140/90 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 mg/kg) and premedicated with fentanyl. Endotracheal intubation was facilitated by the muscle relaxant atracurium 0.5 mg/kg. 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 frequency/percentages 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 <0.05 was taken as statistically significant.

Being tested
Ibuprofen 800 mg, Ketorolac Injection
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibuprofen 800 mgDrug

    Intravenous injection of ibuprofen 800 mg

  • Ketorolac InjectionDrug

    Intravenous injection of Ketorolac 30 mg

Study groups in NCT05695664
Study groupRoleWhat they receive
IbuprofenExperimentalpatient received 800 mg of Ibuprofen IV
Receives: Drug: Ibuprofen 800 mg
KetorolacExperimentalPatients received Keterolac 30 mg IV
Receives: Drug: Ketorolac Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative pain

    Postoperative pain measured by visual analogue scale (VAS), in which 0 is no pain and 10 is the maximum possible bearable pain.

    Measured: 3, 6 and 12 hours in postoperative period

  2. Rescue analgesia requirement

    Inj. Ketorolac 30 mg as Rescue analgesic was used intravenouly when VAS was equal or more than 4

    Measured: 12 hours in the postoperative period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2023
  2. Study start1 Aug 2021
  3. Primary completion31 Jan 2022
  4. Study completion31 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized controlled trial
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05695664
Sponsor's protocol ID
156/05/21
Status last verified
Jan 2023
First submitted
12 Jan 2023
Last updated
25 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Greimel F, Maderbacher G, Zeman F, Grifka J, Meissner W, Benditz A. No Clinical Difference Comparing General, Regional, and Combination Anesthesia in Hip Arthroplasty: A Multicenter Cohort-Study Regarding Perioperative Pain Management and Patient Satisfaction. J Arthroplasty. 2017 Nov;32(11):3429-3433. doi: 10.1016/j.arth.2017.05.038. Epub 2017 May 26.

    PubMed 28641966
  • Hernandez-Boussard T, Graham LA, Desai K, Wahl TS, Aucoin E, Richman JS, Morris MS, Itani KM, Telford GL, Hawn MT. The Fifth Vital Sign: Postoperative Pain Predicts 30-day Readmissions and Subsequent Emergency Department Visits. Ann Surg. 2017 Sep;266(3):516-524. doi: 10.1097/SLA.0000000000002372.

    PubMed 28657940
  • Masala IF, Caso F, Sarzi-Puttini P, Salaffi F, Atzeni F. Acute and chronic pain in orthopaedic and rheumatologic diseases: mechanisms and characteristics. Clin Exp Rheumatol. 2017 May-Jun;35 Suppl 105(3):127-131. Epub 2017 Jun 29.

    PubMed 28681710
  • Lavie LG, Fox MP, Dasa V. Overview of Total Knee Arthroplasty and Modern Pain Control Strategies. Curr Pain Headache Rep. 2016 Nov;20(11):59. doi: 10.1007/s11916-016-0592-6.

    PubMed 27655139
  • Ramia E, Nasser SC, Salameh P, Saad AH. Patient Perception of Acute Pain Management: Data from Three Tertiary Care Hospitals. Pain Res Manag. 2017;2017:7459360. doi: 10.1155/2017/7459360. Epub 2017 Mar 28.

    PubMed 28458592

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Ibuprofen 800 mg and Ketorolac Injection in people with Intravenous Drug Usage and Ibuprofen, run by Benazir Bhutto Hospital, Rawalpindi at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: 3, 6 and 12 hours in postoperative period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05695664, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.

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