15. tran kim phung

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15. tran kim phung

  1. 1. Evaluate the Effects of Ketamine (Pain Relief Drug) in prehospital trauma care: A controlled clinical trial in Quang Tri, Vietnam Dr. PhD. Tran Kim Phung Co-operation between TMC, Oslo University and Quang Tri Health Service
  2. 2. Reason for research <ul><li>Trauma is the big problem. Death by trauma is the first ranking. </li></ul><ul><li>Life support activities such as stop bleeding, airway especially pain relef at community are very limited. </li></ul><ul><li>Morphin is consider the main drug for pain relief in trauma at community but infact it’s very little use. It has adverse event nausea and vomiting and cause opium </li></ul><ul><li>Objective of research: To find out a new pain relief drug to change Morphin </li></ul>
  3. 3. <ul><li>Objective: </li></ul><ul><li>To compare the analgesic effect and adverse events of ketamine analgesia versus morphine analgesia to injury patients during prehospital evacuations </li></ul>
  4. 4. Study population <ul><li>Inclusion criteria </li></ul><ul><li>Any patient in Quang Tri Province, injured during the study period, regardless type of trauma, where prehospital life support is provided by trained health staff, and the patient needs medical assistance during evacuation to Quang Tri Provincial Hospital (QT-PH) in Dong Ha (end-point for this study). </li></ul>
  5. 5. Exclusion criteria <ul><li>Deep unconscious patients (no response to pain stimuli). </li></ul><ul><li>Patients already dead on first medical contact in-field. </li></ul><ul><li>Patients with head or eye injury. </li></ul><ul><li>Infants less than 5 years of age. </li></ul><ul><li>Patients with pre-hospital evacuation time < 10 minutes. </li></ul>
  6. 6. Sampling and recruitment <ul><li>We use systematic cluster sampling: </li></ul><ul><li>We divided the study area of Quang Tri province into two sectors (“Sector 1” and “Sector 2”), each sector having approximately the same number of patients and approximately same transport times. </li></ul><ul><li>Patients injured in one sector get ketamine pain relief (Treatment Group); </li></ul><ul><li>Patients from the other sector get morphine pain relief (Control Group). </li></ul>
  7. 7. Sampling and recruitment <ul><li>To reduce the impact of systematic failures, the sectors would be crossed over every month: Sector 1 shifts to Control, Sector 2 shifts to Treatment. </li></ul><ul><li>Both groups stratified according to injury severity using the Injury Severity Score (ISS, ref. 13): Moderate injuries = ISS <9. Serious injuries = ISS 9 – 15. Major injuries = ISS >15. </li></ul>
  8. 8. Main variables <ul><li>1. Analgesic effect: </li></ul><ul><li>Patient’s actual pain assessed and rated on Visual Analogue Scale (VAS) by the trauma care provider at two points: </li></ul><ul><li>First (VAS1): at the first contact in-field immediately before life support starts. </li></ul><ul><li>Second (VAS2): immediately on admission at QT hospital. </li></ul><ul><li>The difference (VAS1) – (VAS2) is the indicator of analgesic effect. </li></ul><ul><li>VAS1 and VAS2 is rated by the same health worker. VAS3: Pain on admission at QT-hospital rated by the QT hospital-doctors (to validate the accuracy of VAS2 ratings by agreement analysis). </li></ul>
  9. 9. Main variables <ul><li>2.Adverse event: </li></ul><ul><li>Nausea and/or vomiting during the prehospital phase. Based on clinical assessment at end-point plus information from patient, patient’s family and prehospital care provider. </li></ul>
  10. 10. The intervention <ul><li>Ketamine treatment: </li></ul><ul><li>Prehospital pain relief was given by trained health staff (doctors/nurses) in the Quang Tri trauma system. </li></ul><ul><li>VAS1 rating was done immediately before in-field life support starts, as part of the clinical examination. </li></ul><ul><li>The first dose of analgesic was given as soon as the patient’s airway is controlled. </li></ul><ul><li>Repeated doses were given during the transport to QT-hospital according to needs assessment by the trauma health st aff . </li></ul>
  11. 11. The intervention (continue) <ul><li>Ketamine treatment: </li></ul><ul><li>intermittent intravenous dose(s) 0.2 – 0.3mg/kg body weight. The doses are repeated until satisfactory pain relief as assessed by the trauma health staff. Each dose is given slowly. </li></ul><ul><li>If more than one dose of ketamine is provided, also atropine was given to reduce salivation: </li></ul><ul><li>Atropine, vials of 1 mg/ml: One single dose of intravenous atropine 0.1 mg/10 kg body weight. </li></ul>
  12. 12. The intervention (continue) <ul><li>Control treatment: </li></ul><ul><li>One intramuscular dose of morphine 10 mg (adults). </li></ul><ul><li>The treatment data (drugs, dosage, time of doses) was registered in-field by the trauma health st aff and gathered at the end-point by investigator (doctor) </li></ul>
  13. 13. Time schedule <ul><li>The inclusion of patients started 1 August 2007. </li></ul><ul><li>The study was concluded when a minimum 250 consecutively injured patients were included in treatment group and control group. </li></ul>
  14. 14. Main Statistic Model <ul><li>Matched pairs analysis for Diference between VAS1 and VAS2 </li></ul><ul><li>Agreement analysis for evaluation between VAS2 and VAS3 </li></ul><ul><li>T test for continuous variables; Chi-square for categorical variables. </li></ul><ul><li>p value< 0.05 considered as significant difference </li></ul>
  15. 15. Inclusion and Exclusion <ul><li>320 samples collected during research periods </li></ul><ul><li>Exclusion: </li></ul><ul><li>Children <5 years old </li></ul><ul><li>Patients with deep unconscious </li></ul><ul><li>Patients used alcohol/beer before injuries </li></ul><ul><li>Patients given other plus analgesia than ketamine and morphine (diazepam, atropine, declofenac, dolargan) </li></ul><ul><li>Inclusion: 257 patients included (140 in Ketamin and 117 in Morphine) was analysed in this study </li></ul>
  16. 16. Significant difference between VAS1 and VAS2, P<0.0001 No significance between the mean difference across ketamine and morphine group, P>0.05 Matched Pairs (Difference VAS1-VAS2) P= 0.1679 Test across group <.0001 <.0001 <.0001 Prob > |t| 117 140 257 N 2.75 - 3.48 3.14 - 3.75 3.06 - 3.53 95% CI 0.18 0.16 0.12 Std Error 3.11 3.44 3.29 Mean Difference 3.72 3.82 3.78 VAS2 6.84 7.26 7.07 VAS1 Morphine Ketamine
  17. 17. Significant difference between VAS1 and VAS2 in each ISS group, p<0.001 <.0001 <.0001 <.0001 Prob > |t| 99 27 131 N 3.07 - 3.87 2.10 - 3.62 2.93 - 3.56 95% CI 0.20 0.37 0.16 Std Error 3.47 2,86 3.25 Mean Difference 3.78 4.15 3.70 VAS2 7.25 7.01 6.95 VAS1 Sev ere M ajor Mod erate
  18. 18. Significant difference between VAS1 and VAS2 in each group , No significance difference between the mean difference across Ketamine and morphine group in ISS 0.33 0.47 0.53 Mean Difference Prob>F Prob>F Prob>F Test Across Groups <.0001 <.0001 <.0001 <.0001 0.0005 <.0001 Prob > |t| 47 52 55 76 15 12 N 2.67 3.11 2.59 2.93 1.39 2.22 Lower95% 3.87 4.21 3.62 3.76 3.90 4.03 Upper95% 0.30 0.27 0.26 0.21 0.59 0.41 Std Error 3.27 3.66 3.11 3.35 2.65 3.12 Mean Difference 3.65 3.89 3.69 3.70 4.09 4.22 VAS2 6.92 7.55 6.80 7.05 6.73 7.35 VAS1 Morphine Ketamine Morphine Ketamine Morphine Ketamine Severe Moderate Major ISS group
  19. 19. Significant difference between VAS1 and VAS2 in each group , No significance between the mean difference across male and female group, p>0.05 0.16 Mean Difference Prob>F Test Across Groups <.0001 <.0001 <.0001 Prob > |t| 66 191 257 N 2.62 3.08 3.06 Lower95% 3.67 3.61 3.53 Upper95% 0.26 0.13 0.12 Std Error 3.15 3.34 3.29 Mean Difference 3.70 3.81 3.78 VAS2 6.85 7.15 7.07 VAS1 FEMALE MALE GENDER
  20. 20. 6 15 7 14 21 n   P=0.40 P=0.45 Mean Difference   Test Across Groups   0.0068 0.0001 0.0045 0.0001 <.0001 Prob > |t|   1.54 1.65 1.13 1.98 2.11 Lower95%   5.77 3.94 3.95 4.60 3.97 Upper95%   0.82 0.53 0.58 0.61 0.45 Std Error   3.65 2.79 2.54 3.29 3.04 Mean Difference   3.82 4.28 4.4 4.02 4.15 VAS2   7.47 7.07 6.94 7.31 7.19 VAS1   Female Male Morphine Ketamine AGE < 15
  21. 21. <ul><li>Significant difference between VAS1 and VAS2 in each group , </li></ul><ul><li>No significance between the mean difference across male and female group; and ketmaine and morphine group in AGE less than 15. </li></ul>
  22. 22. 1.021 0.173 Mean Difference F Ratio Prob>F Test Across Groups <.0001 <.0001 <.0001 <.0001 <.0001 Prob > |t| 35 152 85 102 187 N 2.20 3.04 2.60 3.09 2.99 Lower95% 3.74 3.65 3.49 3.82 3.55 Upper95% 0.38 0.15 0.23 0.18 0.14 Std Error 2.97 3.34 3.05 3.45 3.27 Mean Difference 3.73 3.83 3.82 3.80 3.81 VAS2 6.70 7.17 6.87 7.25 7.08 VAS1 FEMALE MALE MORPHINE KETAMINE Age (15-54)
  23. 23. Age (15-54) <ul><li>Significant difference between VAS1 and VAS2 in each group , P<0.0001 </li></ul><ul><li>No significance between the mean difference across male and female group; ketamine and morphine group in AGE of 15-54. P>F </li></ul>
  24. 24. 0.41 0.95 Mean Difference Prob>F Prob>F Test Across Groups <.0001 <.0001 <.0001 <.0001 <.0001 Prob > |t| 25 24 25 24 49 N 2.45 3.18 2.74 2.82 3.00 Lower95% 4.13 4.20 4.26 4.12 3.97 Upper95% 0.41 0.25 0.37 0.32 0.24 Std Error 3.29 3.69 3.5 3.47 3.48 Mean Difference 3.63 3.35 3.21 3.78 3.49 VAS2 6.91 7.04 6.71 7.25 6.98 VAS1 FEMALE MALE MORPHINE KETAMINE AGE>=55
  25. 25. Age >= 55 <ul><li>Significant difference between VAS1 and VAS2 in each group , P<0.0001 </li></ul><ul><li>No significance between the mean difference across male and female group; ketamine and morphine group in AGE of 55-90. p>F </li></ul>
  26. 26. Significantly difference between nausea and/ or vomit with much higher rate in morphine group, P<0.0001 20 27.35 32 30.77 36 MORPHINE n=117 0 0 2.14 3 5.00 7 KETAMINE n=140 Percent Nausea & vomit Percent Vomit Percent Nausea
  27. 27. B. Agreement analysis VAS2 & VAS3 -0.08 - 0.08 -0.11 Agreement index (AI)=1- 2SD (Dif) / mean level 8/117= 6.8% 7/140= 5.7% 11/257 = 4.3% Percentage (%) outliers 4.48 4.08 4.36 Agreement limit (2SDdiff ) -0.82 0.08 -0.32 Mean difference 4.13 3.78 3.92 Mean level Morphine Ketamine Statistics Parameters
  28. 28. Conclusions <ul><li>1.Pain relief effect of Ketamine is the same pain relef effect of morphine. </li></ul><ul><li>2.Pain relief effect of Ketamine is clear in each ISS group </li></ul><ul><li>3.Pain relief effect of Ketamine is clear in each age, and gender group. </li></ul><ul><li>4.Adverse effect (vomiting/nausea) much lower in Ketamine group than morphine </li></ul>
  29. 29. Discussions <ul><li>Ketamine should be used as pain relief in trauma care outside the hospital </li></ul><ul><li>How to change the doctors/nurses’ habit to use ketamine rather than morphine in community? </li></ul>
  30. 30. <ul><li>Thank you </li></ul>

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