Abdominal Surgery, Liver Dysfunction, Multiorgan Failure, Renal Failure, Respiratory Failure
Conditions
Keywords
Tramadol, CYP2D6 polymorphism, analgesia, intensive care, organ failure
Brief summary
Tramadol is opioid analgesic widely used to treat moderate to severe pain. It is metabolized by cytochrome CYP2D6 into two major metabolites: pharmacologically active metabolite O-desmethyltramadol (M1) and inactive N-desmethyltramadol (M2), respectively. Tramadol kinetics in a population of patients undergoing major abdominal surgical procedures, and in patients with a greater or lesser degree of organic failure, is still not well researched. The investigators will measure plasma concentrations of tramadol and its metabolites after usual tramadol doses in ICU patients after major abdominal surgery. Also analgesic affect and side effect of tramadol will be recorded.
Detailed description
The blood samples for the CYP2D6 gene polymorphism analysis will be taken from all patients included in the study. The patients will be categorized as slow (PM), normal (NM) or ultra-fast metabolizers (UM) of tramadol using analysis of the CYP2D6 phenotype. Standard laboratory findings including red blood cells, urea, creatinine, and cholinesterase will be done before surgery. The patients will receive 500 mg of tramadol intravenously divided into 5 doses during the first 24 postoperative hours in the ICU. The plasma concentrations of tramadol, O-desmethyltramadol and N-desmethyltramadol will be measured 1, 2 and 4 hours after the first dose, and immediately before the 2nd, 3rd and 5th dose. There will therefore be 6 measurements of tramadol and its metabolites. The analgesic effect of tramadol will be measured in awake patients with Numeric Rating Scale - NRS (0 - without pain, 10 - strong pain) 30 minutes before and 30 minutes after tramadol administration. The NRS value of 3 or less will be considered as adequate analgesia. In case of inadequate analgesia rescue analgesic (morphine) will be used according to the local protocol. In unconscious patients the analgesic effect of tramadol will be tested by Critical Care Pain Observation Tool (CPOT). The CPOT value of less than 2 will be considered as adequate analgesia. In case of inadequate analgesia rescue analgesic (morphine) will be used according to the local protocol. During the first 24 hours side effect of tramadol, such as nausea, vomiting and new respiratory depression will be recorded.
Interventions
DRUGPostoperative analgesia using tramadol
Tramadol 100 mg will be given to the patients in the postoperative period.
Sponsors
Josip Juraj Strossmayer University of Osijek
Osijek University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* patients after major abdominal surgery will be observed. * surgical interventions requiring a laparotomy and involving resection of the organs of the digestive system * postoperative ICU admission.
Exclusion criteria
* allergic reaction to tramadol * patients under 18 years old * patient over 90 years old * BMI \<18 and \>35 * laparoscopic surgery * chronic therapy with tramadol, cimetidine, paroxetine, pimozide, metoclopramide, amiodarone, olanzapine, chlorpromazine, fluphenazine, haloperidol, thioridazine, risperidone and clozapine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1, 2, and 4 hours after first dose and immediately before 2nd, 3rd, and 5th dose, up to 24 hours | The plasma concentrations of tramadol, O-desmethyltramadol (ODT) and N-desmethyltramadol (NDT) will be measured 1, 2 and 4 hours after the first dose of 100 mg tramadol i.v., and immediately before the 2nd, 3rd and 5th dose. There will therefore be 6 measurements of tramadol and its metabolites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | Before each dose of tramadol and 30 minutes after tramadol dose, up to 24 hours | The analgesic effect of tramadol will be measured in awake patients with Numeric Rating Scale (NRS, 0 - without pain, 10 - the worst pain) 30 minutes before and 30 minutes after tramadol administration. The NRS value of 3 or less will be considered as adequate analgesia. In case of inadequate analgesia morphine will be used according to the local protocol. |
| Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | Pain was assessed before and 30 minutes after each tramadol dose, up to 24 hours. | In unconsciousness patents, the analgesic effect of tramadol will be tested by Critical Care Pain Observation Tool (CPOT). Highest score on a scale is 8 (worst pain) and lowest is 0 (no pain). The CPOT value of less than 2 will be considered as adequate analgesia. |
| Number of Participants With Nausea and Vomiting After Tramadol | Nausea and vomiting was assessed during first 30 minutes after tramadol administration | Nausea and/or vomiting during treatment with tramadol in ICU will be recorded. |
| Number of Patients With Respiratory Depression After Tramadol | Respiratory depression was observed up to 30 minutes after tramadol administration | Respiratory depression after tramadol is considered to be any drop in saturation below 90% or drop in respiratory rate below 10/min. |
| Length of ICU Stay | Up to 6 months | Length of stay in ICU will be recorded and correlated with standard laboratory values and tramadol and metabolites concentration. |
Countries
Croatia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Adult Patients Undergoing Major Open Abdominal Surgery Observational study. In the patients undergoing major open abdominal surgery for cancer tramadol will be used for postoperative analgesia. In the postoperative period parent compound and metabolites of tramadol will be measured. Postoperative analgesia and adverse effects will be registered and compared between CYP2D6 phenotypes observed.
Postoperative analgesia using tramadol: Tramadol 100 mg will be given to the patients in the postoperative period. | 47 |
| Total | 47 |
Baseline characteristics
| Characteristic | Adult Patients Undergoing Major Open Abdominal Surgery |
|---|---|
| Age, Continuous | 67 years |
| ASA status ASA II | 11 Participants |
| ASA status ASA III | 27 Participants |
| ASA status ASA IV | 8 Participants |
| ASA status ASA V | 1 Participants |
| Body mass index | 26.1 kg/m^2 |
| CYP2D6 polymorphism *1/*1 | 22 Participants |
| CYP2D6 polymorphism *1/*1xN | 1 Participants |
| CYP2D6 polymorphism *1/*3 | 2 Participants |
| CYP2D6 polymorphism *1/*4 | 16 Participants |
| CYP2D6 polymorphism *1/*4xN | 3 Participants |
| CYP2D6 polymorphism *4/*4 | 2 Participants |
| Metabolic phenotype Extensive | 22 Participants |
| Metabolic phenotype Intermediate | 22 Participants |
| Metabolic phenotype Poor | 2 Participants |
| Metabolic phenotype Ultrafast | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 47 Participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 12 / 22 | 4 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype
The plasma concentrations of tramadol, O-desmethyltramadol (ODT) and N-desmethyltramadol (NDT) will be measured 1, 2 and 4 hours after the first dose of 100 mg tramadol i.v., and immediately before the 2nd, 3rd and 5th dose. There will therefore be 6 measurements of tramadol and its metabolites.
Time frame: 1, 2, and 4 hours after first dose and immediately before 2nd, 3rd, and 5th dose, up to 24 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tramadol Concentration | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 181.2 mcg/L |
| Tramadol Concentration | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 300.1 mcg/L |
| Tramadol Concentration | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 372.7 mcg/L |
| Tramadol Concentration | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 232.1 mcg/L |
| Tramadol Concentration | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 408.5 mcg/L |
| Tramadol Concentration | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 270.6 mcg/L |
| ODT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 7.6 mcg/L |
| ODT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 29.7 mcg/L |
| ODT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 7.05 mcg/L |
| ODT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 19.1 mcg/L |
| ODT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 12.4 mcg/L |
| ODT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 10 mcg/L |
| ODT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 19.1 mcg/L |
| ODT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 51.7 mcg/L |
| ODT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 15.7 mcg/L |
| ODT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 20.2 mcg/L |
| ODT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 17.1 mcg/L |
| ODT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 36.6 mcg/L |
| ODT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 40.9 mcg/L |
| ODT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 75.1 mcg/L |
| ODT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 38.1 mcg/L |
| ODT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 46.4 mcg/L |
| ODT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 46.7 mcg/L |
| ODT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 97.4 mcg/L |
| ODT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 58.2 mcg/L |
| ODT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 13.8 mcg/L |
| ODT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 26 mcg/L |
| ODT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 25.1 mcg/L |
| ODT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 61.9 mcg/L |
| ODT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 19.4 mcg/L |
| NDT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 71.4 mcg/L |
| NDT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 11.7 mcg/L |
| NDT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 15.3 mcg/L |
| NDT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 28.9 mcg/L |
| NDT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 31.2 mcg/L |
| NDT Concentration in Poor Metabolizers (PM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 180.5 mcg/L |
| NDT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 20.2 mcg/L |
| NDT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 34.9 mcg/L |
| NDT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 6.1 mcg/L |
| NDT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 9.6 mcg/L |
| NDT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 9.1 mcg/L |
| NDT Concentration in Intermediate Metabolizers (IM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 4.5 mcg/L |
| NDT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 9.7 mcg/L |
| NDT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 8.5 mcg/L |
| NDT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 19 mcg/L |
| NDT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 5.2 mcg/L |
| NDT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 4.76 mcg/L |
| NDT Concentration in Extensive Metabolizers (EM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 34.4 mcg/L |
| NDT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 4th measurement | 3.5 mcg/L |
| NDT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 2nd measurement | 3.5 mcg/L |
| NDT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 6th measurement | 18.1 mcg/L |
| NDT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 3rd measurement | 3.5 mcg/L |
| NDT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 5th measurement | 9.8 mcg/L |
| NDT Concentration in Ultrafast Metabolizers (UM) | Serum Concentration of Tramadol and Tramadol Metabolites With Respect to Metabolic Phenotype | 1st measurement | 3.5 mcg/L |
Secondary
Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT)
In unconsciousness patents, the analgesic effect of tramadol will be tested by Critical Care Pain Observation Tool (CPOT). Highest score on a scale is 8 (worst pain) and lowest is 0 (no pain). The CPOT value of less than 2 will be considered as adequate analgesia.
Time frame: Pain was assessed before and 30 minutes after each tramadol dose, up to 24 hours.
Population: All unconscious patients had low CPOT values and were therefore not suitable for statistical analysis.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 2nd assessment point | 0 score on a scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 4th assessment point | 0 score on a scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 3rd assessment point | 0 score on a scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 5th assessment point | 0 score on a scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 1st assessment point | 0 score on a scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 5th assessment point | 0 score on a scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 1st assessment point | 0 score on a scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 2nd assessment point | 0 score on a scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 3rd assessment point | 0 score on a scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Critical Care Pain Observation Tool (CPOT) | 4th assessment point | 0 score on a scale |
Secondary
Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS)
The analgesic effect of tramadol will be measured in awake patients with Numeric Rating Scale (NRS, 0 - without pain, 10 - the worst pain) 30 minutes before and 30 minutes after tramadol administration. The NRS value of 3 or less will be considered as adequate analgesia. In case of inadequate analgesia morphine will be used according to the local protocol.
Time frame: Before each dose of tramadol and 30 minutes after tramadol dose, up to 24 hours
Population: Pain was assessed by the NRS scale in patients who were awake.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 2nd pain assessment | 5 score on scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 4th pain assessment | 4 score on scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 3rd pain assessment | 3.5 score on scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 5th pain assessment | 3 score on scale |
| Tramadol Concentration | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 1st pain assessment | 7 score on scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 5th pain assessment | 2 score on scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 1st pain assessment | 5 score on scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 2nd pain assessment | 3 score on scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 3rd pain assessment | 2 score on scale |
| ODT Concentration in Poor Metabolizers (PM) | Analgesic Effect of Tramadol Measured by Numeric Rating Scale (NRS) | 4th pain assessment | 2 score on scale |
Secondary
Length of ICU Stay
Length of stay in ICU will be recorded and correlated with standard laboratory values and tramadol and metabolites concentration.
Time frame: Up to 6 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Tramadol Concentration | Length of ICU Stay | 1.5 days |
| ODT Concentration in Poor Metabolizers (PM) | Length of ICU Stay | 1 days |
Secondary
Number of Participants With Nausea and Vomiting After Tramadol
Nausea and/or vomiting during treatment with tramadol in ICU will be recorded.
Time frame: Nausea and vomiting was assessed during first 30 minutes after tramadol administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tramadol Concentration | Number of Participants With Nausea and Vomiting After Tramadol | 12 Participants |
| ODT Concentration in Poor Metabolizers (PM) | Number of Participants With Nausea and Vomiting After Tramadol | 4 Participants |
Secondary
Number of Patients With Respiratory Depression After Tramadol
Respiratory depression after tramadol is considered to be any drop in saturation below 90% or drop in respiratory rate below 10/min.
Time frame: Respiratory depression was observed up to 30 minutes after tramadol administration
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Tramadol Concentration | Number of Patients With Respiratory Depression After Tramadol | 0 Participants |