Nachum Nesher1, Margaret P Ekstein2, Yoseph Paz1, Nissim Marouani3, Shoshana Chazan3, Avi A Weinbroum4. 1. Department of Cardiothoracic Surgery, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 2. Department of Anesthesia and Intensive Care Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 3. Acute Pain Service, Department of Anesthesia and Intensive Care Medicine, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. 4. Department of Anesthesia and Intensive Care Medicine, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: draviw@tasmc.health.gov.il.
Abstract
BACKGROUND: Thoracotomy is associated with severe pain. We hypothesized that the concomitant use of a subanesthetic dose of ketamine plus a two-third-standard morphine dose might provide more effective analgesia with fewer side effects than a standard morphine dose for early pain control. METHODS: We conducted a 6-month randomized, double-blind study in patients undergoing thoracotomy for minimally invasive direct coronary artery bypass or for lung tumor resection. After extubation, when objectively awake (>or= 5/10 visual analogue scale [VAS]) and complaining of pain (>or= 5/10 VAS), patients were connected to patient-controlled IV analgesia delivering 1.5 mg of morphine plus saline solution (MO) or 1.0 mg of morphine plus a 5-mg ketamine bolus (MK), with a 7-min lockout time. Rescue IM diclofenac, 75 mg, was available. Follow-up lasted 4 h. RESULTS:Forty-one patients completed the study. MO patients (n = 20) used 6.8 +/- 1.9 mg/h (mean +/- SD) and 5.5 +/- 3.6 mg/h of morphine during the first and second hours, respectively; MK patients (n = 21) used 3.7 +/- 1.2 mg/h and 2.8 +/- 2.3 mg/h, respectively (p < 0.01). The 4-h activation rate of the device was double in the MO patients than in the MK patients (66 +/- 54 vs 28 +/- 20, p < 0.001). The maximal self-rated pain score was 5.6 +/- 1.0 for the MO group vs 3.7 +/- 0.7 for the MK group (p < 0.01). Four MO patients vs one MK patient required diclofenac; 6 MO patients but no MK patients had oxygen saturation by pulse oximetry < 94% on a fraction of inspired oxygen of 0.4 (p < 0.01); two MO patients required reintubation. Paco(2) was higher in the MO group (40 +/- 6 mm Hg vs 33 +/- 5 mm Hg, p < 0.05). Heart rate, BP, and incidence of nausea/vomiting were similar; no ketamine-related hallucinations were detected. CONCLUSIONS:Subanesthetic ketamine combined with a 35%-lower morphine dose provided equivalent pain control compared to the standard morphine dose alone, with fewer adverse side effects and a 45% reduction in morphine consumption. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00625911.
RCT Entities:
BACKGROUND: Thoracotomy is associated with severe pain. We hypothesized that the concomitant use of a subanesthetic dose of ketamine plus a two-third-standard morphine dose might provide more effective analgesia with fewer side effects than a standard morphine dose for early pain control. METHODS: We conducted a 6-month randomized, double-blind study in patients undergoing thoracotomy for minimally invasive direct coronary artery bypass or for lung tumor resection. After extubation, when objectively awake (>or= 5/10 visual analogue scale [VAS]) and complaining of pain (>or= 5/10 VAS), patients were connected to patient-controlled IV analgesia delivering 1.5 mg of morphine plus saline solution (MO) or 1.0 mg of morphine plus a 5-mg ketamine bolus (MK), with a 7-min lockout time. Rescue IM diclofenac, 75 mg, was available. Follow-up lasted 4 h. RESULTS: Forty-one patients completed the study. MO patients (n = 20) used 6.8 +/- 1.9 mg/h (mean +/- SD) and 5.5 +/- 3.6 mg/h of morphine during the first and second hours, respectively; MKpatients (n = 21) used 3.7 +/- 1.2 mg/h and 2.8 +/- 2.3 mg/h, respectively (p < 0.01). The 4-h activation rate of the device was double in the MO patients than in the MKpatients (66 +/- 54 vs 28 +/- 20, p < 0.001). The maximal self-rated pain score was 5.6 +/- 1.0 for the MO group vs 3.7 +/- 0.7 for the MK group (p < 0.01). Four MO patients vs one MKpatient required diclofenac; 6 MO patients but no MKpatients had oxygen saturation by pulse oximetry < 94% on a fraction of inspired oxygen of 0.4 (p < 0.01); two MO patients required reintubation. Paco(2) was higher in the MO group (40 +/- 6 mm Hg vs 33 +/- 5 mm Hg, p < 0.05). Heart rate, BP, and incidence of nausea/vomiting were similar; no ketamine-related hallucinations were detected. CONCLUSIONS: Subanesthetic ketamine combined with a 35%-lower morphine dose provided equivalent pain control compared to the standard morphine dose alone, with fewer adverse side effects and a 45% reduction in morphine consumption. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00625911.
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