Postoperative Pain Management, Urolithiasis
Conditions
Keywords
Sprix, Intranasal ketoralac, Ketoralac, Urolithiasis, Kidney stone, Uretal stone, Ureteroscopic removal of stones, URS, Pain management, Pain
Brief summary
Despite an overall reduction in the perioperative complication rate, post operative pain management after ureteroscopic removal of stones (URS) remains a major factor delaying discharge of patients. The investigators hypothesize that perioperative usage of intranasal ketorolac will provide a reduction in post operative opioid requirements, better post operative pain control, higher anesthesia satisfaction and faster recovery.
Detailed description
The prevalence and incidence of urolithiasis, or kidney stone disease, are increasing in the general population. Life-time incidence of urolithiasis is estimated to be between 5%- 12%. The treatment of kidney stones depends on stone type and size, symptom severity, and the presence of obstruction. URS is a common ambulatory procedure as improved technological advances and increased clinical utilization have helped decrease postoperative complications. Despite an overall reduction in the perioperative complication rate, post operative pain management after URS remains a major factor delaying discharge of patients. Post operative pain after URS is usually treated with opioids and non steroidal anti inflammatory drugs. Intranasal ketorolac (SprixTM) is an FDA approved pain formulation for short term management (5 days) of moderate to moderately severe pain that requires analgesia at the opioid level. The efficacy of intranasal ketorolac formulation was demonstrated in placebo-controlled studies in patients following major surgeries. The primary objective of the study is to evaluate the role perioperative usage of single-dose of intranasal ketorolac on immediate post operative opioid requirements. Secondary objectives of the study are to (a) evaluate the post operative pain score 30 minutes after surgery, 1 hour after surgery, and 2 hours after surgery, (b) find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population, (c) find the level of anesthesia satisfaction in the target population, (d) find the time to discharge in the target population, (e) compare the two groups post anesthesia discharge score.
Interventions
DRUGIntranasal Ketoralac
15.75 mg of Sprix in each nostril 20 minutes before end of surgery
DRUGPlacebo
15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
Sponsors
Montefiore Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ureteroscopic stone removal surgeries with stenting * Age ≥ 18 years and \< 65 years * Stable patient with stable vital signs * Mentally competent and is able to understand consent form
Exclusion criteria
* Unstable patients * Patients with multiple trauma sites * Patients with allergies to ketorolac or any of the components in the nasal spray preparation * Patients with active peptic ulcer disease * History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs * Renal disease or at risk for renal failure due to volume depletion * Pregnant or nursing mothers * Nasal abnormality or illness that could affect the absorption of intranasal medication (such as: nasal discharge, rhinitis, acute upper respiratory infection, acute epistaxis, nasal polyp, nasal tumor) * Any other contraindication to the use of Sprix, or in whom use of Sprix would not be consistent with the approved package insert
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Opioid Requirements | 3 hours after surgery | this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain Score | 30 minutes after surgery | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. |
| Post Operative Pain Scale | 2 hours after surgery | To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Side Effects | 24 hours after procedure | To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intranasal Ketoralac A single dose of Sprix (31.5 mg) will be administered to patients 20 minutes before the end of surgery. 15.75 mg of Sprix will be sprayed in each nostril.
Intranasal Ketoralac: 15.75 mg of Sprix in each nostril 20 minutes before end of surgery | 20 |
| Placebo A single dose of placebo will be administered 20 minutes before the end of surgery. 15.75 mg of the placebo will be sprayed in each nostril.
Placebo: 15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery | 23 |
| Total | 43 |
Baseline characteristics
| Characteristic | Placebo | Total | Intranasal Ketoralac |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 43 Participants | 20 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 9.3 | 48 years STANDARD_DEVIATION 11 | 47 years STANDARD_DEVIATION 12.4 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 23 participants | 43 participants | 20 participants |
| Sex: Female, Male Female | 11 Participants | 21 Participants | 10 Participants |
| Sex: Female, Male Male | 12 Participants | 22 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 23 |
| other Total, other adverse events | 0 / 20 | 0 / 23 |
| serious Total, serious adverse events | 0 / 20 | 0 / 23 |
Outcome results
Primary
Post-operative Opioid Requirements
this study will assess the effect of perioperative usage of single-dose of intranasal ketorolac on post operative opioid requirements within 3 hours after surgery.
Time frame: 3 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intranasal Ketoralac | Post-operative Opioid Requirements | 27.43 mg |
| Placebo | Post-operative Opioid Requirements | 30 mg |
Secondary
Post Operative Pain Scale
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 2 hours after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
Time frame: 2 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intranasal Ketoralac | Post Operative Pain Scale | 4 score on a scale |
| Placebo | Post Operative Pain Scale | 3 score on a scale |
Secondary
Post Operative Pain Score
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 30 minutes after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
Time frame: 30 minutes after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intranasal Ketoralac | Post Operative Pain Score | 4 score on a scale |
| Placebo | Post Operative Pain Score | 3.5 score on a scale |
Secondary
Post Operative Pain Score
To evaluate the post operative pain score using the Visual Analog Scale (VAS) 1 hour after surgery. The scale for VAS is 0 is no pain to 10 being the worst pain.
Time frame: 1 hour after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intranasal Ketoralac | Post Operative Pain Score | 3.5 score on a scale |
| Placebo | Post Operative Pain Score | 4.5 score on a scale |
Other Pre-specified
Incidence of Postoperative Side Effects
To find the incidence of immediate (until discharge) and 24hrs post operative side effects in the target population.
Time frame: 24 hours after procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intranasal Ketoralac | Incidence of Postoperative Side Effects | 0 number of events |
| Placebo | Incidence of Postoperative Side Effects | 0 number of events |