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Low-dose ketamine infusion reduces postoperative hydromorphone requirements in opioid-tolerant patients following spinal fusion: A randomised controlled trial

Boenigk, Kirsten; Echevarria, Ghislaine C; Nisimov, Emmanuel; von Bergen Granell, Annelise E; Cuff, Germaine E; Wang, Jing; Atchabahian, Arthur
BACKGROUND:The current opioid epidemic highlights the urgent need for effective adjuvant therapies to complement postoperative opioid analgesia. Intra-operative ketamine infusion has been shown to reduce postoperative opioid consumption and improve pain control in opioid-tolerant patients after spinal fusion surgery. Its efficacy for opioid-naïve patients, however, remains controversial. OBJECTIVE:We hypothesised that low-dose ketamine infusion after major spinal surgery reduces opioid requirements in opioid-tolerant patients, but not in opioid-naïve patients. DESIGN/METHODS:Randomised placebo-controlled prospective study. SETTING/METHODS:Single-centre, tertiary care hospital, November 2012 until November 2014. PATIENTS/METHODS:A total of 129 patients were classified as either opioid-tolerant (daily use of opioid medications during 2 weeks preceding the surgery) or opioid-naïve group, then randomised to receive either ketamine or placebo; there were thus four groups of patients. All patients received intravenous hydromorphone patient-controlled analgesia postoperatively. INTERVENTION/METHODS:Patients in the ketamine groups received a ketamine infusion (bolus 0.2 mg kg over 30 min followed by 0.12 mg kg h for 24 h). Patients in the placebo groups received 0.9% saline. MAIN OUTCOME MEASURES/METHODS:The primary outcome was opioid consumption during the first 24 h postoperatively. The secondary outcome was numerical pain scores during the first 24 h and central nervous system side effects. RESULTS:Postoperative hydromorphone consumption was significantly reduced in the opioid-tolerant ketamine group, compared with the opioid-tolerant placebo group [0.007 (95% CI 0.006 to 0.008) versus 0.011 (95% CI 0.010 to 0.011) mg kg h, Bonferroni corrected P < 0.001]. There was no difference in hydromorphone use between the opioid-naïve groups (0.004 and 0.005 mg kg h in the opioid-naïve ketamine and placebo group, respectively, P = 0.118). Pain scores did not differ significantly between the opioid-tolerant ketamine group and the opioid-naïve groups. There was no significant difference in side effects among groups. CONCLUSION/CONCLUSIONS:Postoperative low-dose ketamine infusion reduces opioid requirements for the first 24 h following spinal fusion surgery in opioid-tolerant, but not in opioid-naïve patients. TRIAL REGISTRATION/BACKGROUND:NCT03274453 with
PMID: 30113350
ISSN: 1365-2346
CID: 3242942

Preoperative autologous blood donation does not affect pre-incision hematocrit in ais patients. A retrospective cohort of a prospective randomized trial [Meeting Abstract]

Peters, A; Verma, K; Diefenbach, C; Hoelscher, C M; Huncke, T K; Boenigk, K; Errico, T J; Lonner, B S
BACKGROUND CONTEXT: Pre-donation of autologous blood prior to spine fusion for adolescent idiopathic scoliosis (AIS) has been common practice. However, the effect of predonation on pre-incision hematocrit has not been studied. This study aims to determine if pre-donation of autologous blood leads to a lower pre-incision hematocrit. PURPOSE: To compare the effects of autologous blood donation on preincisional hematocrit levels. STUDY DESIGN/SETTING: Retrospective cohort study of prospective randomized trial. PATIENT SAMPLE: Patients (ages 10-21) undergoing posterior spinal fusion in a prospective, randomized controlled trial in which 125 patients were randomized to TXA, EACA, or Saline for surgery from January 2009 to January 2011. Of the 125 patients that enrolled in the study, 28 patients donated blood and 62 patients did not donate blood. 35 patients were omitted as the autologous blood donation status was not clearly documented in the medical record. OUTCOME MEASURES: Primary outcome measure was the pre-incisional hematocrit of patients immediately prior to surgery. METHODS: This is a retrospective review of data from a prospective, randomized controlled trial in which 125 patients were randomized to TXA, EACA, or Saline for surgery from January 2009 to January 2011. As part of the prospective study, all patients had a complete blood count (CBC) drawn just prior to incision. Of the 125 patients that enrolled in the study, 28 patients donated blood and 62 patients did not donate blood. 35 patients were omitted as the autologous blood donation status was not clearly documented in the medical record. Patient demographics and CBC values were compared between groups using a T-test. Statistical significance was achieved at P<0.05. RESULTS: Pre-donation patients (n528) had an average age of 15.662.2and were 75% female (21F, 7M) which was comparable to non-donation patients (n562) who had a mean age of 15.0 +/- 2.3 and were 82% female (51F, 11M) (p=0.259, p=0.425 respectively). However, pre-donation!
ISSN: 1529-9430
CID: 628112

Are anti-fibrinolytics effective at reducing peri-operative blood loss in adolescent idiopathic scoliosis? [Meeting Abstract]

Hoelscher C.; Verma K.; Errico T.; Dryer J.; Huncke T.; Boenigk K.; Lonner B.
BACKGROUND CONTEXT: Anti-fibrinolytics have been proven effective in reducing intra-operative blood loss in several settings. However, their value in Adolescent Idiopathic Scoliosis (AIS) remains unclear. No previous study has compared tranexamic acid (TXA), epsilon aminocaproic acid (EACA), and placebo in regards to their ability to limit operative blood loss, post-operative drain output, and transfusion rate. PURPOSE: To determine the efficacy of intra-operative anti-fibrinolytics at reducing peri-operative blood loss and transfusion rate in patients with adolescent idiopathic scoliosis undergoing posterior spinal fusion of at least 5 levels. STUDY DESIGN/SETTING: Prospective, double-blind, randomized clinical trial. PATIENT SAMPLE: Patients between the ages of 10-21 with a diagnosis of adolescent idiopathic scoliosis treated with posterior spinal fusion of at least five levels were prospectively enrolled. OUTCOME MEASURES: Primary outcome measures include estimated blood loss, drain output, total blood loss, and transfusion rate. Secondary outcome measures include pre-, intra-, and post-operative hematocrit, duration of surgery, complications, and length of hospital stay. METHODS: This is a prospective, randomized, double-blind comparison of TXA, EACA and placebo used intra-operatively in patients with AIS. 119 AIS patients were randomly assigned to TXA, EACA, or control. TXA was administered at 10 mg/ kg for a loading dose followed by 1 mg/kg-hr, while EACA was given at a 10 fold higher dose. Parameters recorded included estimated blood loss (EBL), pre, intra and post-operative hematocrit, blood product usage, post-operative drain output, and total blood loss. RESULTS: 119 patients were randomized to TXA (n535), EACA (n538), or placebo (n546). There were 93 females and 26 males, average age 15. Most pre-operative characteristics were similar, however saline patients had significantly greater height, weight, and estimated blood volume vs TXA (p<.05). TXA patients had significantly lower hematocrit at anesthesia start vs saline (33.2 vs 35.7, p<.05). There was no difference in transfusion rate, duration of surgery, levels fused, or anchors placed. When controlling for mean arterial pressure (MAP) during exposure, TXA reduced EBL vs saline (p<.05), and reduced total blood loss, total blood loss per anchor, and total blood loss per degree of curve vs saline (p<.05). Additionally, EACA reduced EBL per anchor vs saline in patients with reduced mean exposure MAP (p<.05). Neither TXA nor EACA reduced EBL or total blood loss in patients with mean exposure MAPO75. While total drain output was not reduced for TXA or EACA vs saline, TXA showed reduced drain output per anchor and degree curve (p<.05) compared to saline. CONCLUSIONS: Our results suggest that anti-fibrinolytics safely reduce blood loss in patients with AIS. However, transfusion rates were not impacted. Further, mean arterial pressure during surgical exposure appears to be a critical factor in the efficacy of anti-fibrinolytic action
ISSN: 1529-9430
CID: 139769