Assessing the effectiveness of perioperative s-ketamine on new-onset headache after resective epilepsy surgery (ESPAIN-trial): protocol for a randomised, double-blind, placebo-controlled trial

Sloekers, Jiske Cornelia Theresa; Bos, Michaël J.; Hoogland, Govert; Bastiaenen, Caroline; Kuijk, Sander M. J. van; Theunissen, Maurice; Rijkers, Kim; Dings, J.; Colon, Albert; Rouhl, Rob P.W.; Schijns, Olaf

doi:10.1136/bmjopen-2019-030580

Cited by 2 publications

(1 citation statement)

References 29 publications

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“…Evidence suggests esketamine is an effective pharmacological option for pain relief. Esketamine can be used as an adjuvant analgesic and reduce the consumption of opioid analgesics in patients undergoing spinal surgery or craniotomy ( 16 , 17 ), and has utility in the routine treatment of refractory pain ( 18 ).…”

Section: Discussionmentioning

confidence: 99%

Safety and efficacy of esketamine for postoperative analgesia in pediatric patients with hypospadias

Chen²,

Li³

et al. 2023

Front. Surg.

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ObjectiveTo explore the safety and efficacy of the combination of continuous intravenous infusion of esketamine with sacral block for postoperative analgesia in pediatric patients undergoing surgery for hypospadiasMethodsPediatric patients (n = 77) undergoing surgery for hypospadias were randomized into two groups: a hydromorphone group (H group, initial dose, 0.02 mg/kg; maintenance dose, 0.01 mg/kg/h) or an esketamine group (E group, initial dose, 0.3 mg/kg; maintenance dose 0.15 mg/kg/h). Caudal epidural block involved injection of 0.2% ropivacaine 1 ml/kg through the sacral hiatus. Age, weight, grade of hypospadias, intraoperative blood loss, operative time, and awaking time of patients were recorded. The Face, Legs, Activity, Cry and Consolability (FLACC) scale and Ramsay sedation scores were recorded when leaving the PACU (0 h) and at postoperative 2, 6, 12, 24, 36, and 48 h. The Pediatric Anesthesia Emergence Delirium Scale (PAED), incidence of hypotension, respiratory depression, nausea and vomiting and pruritus, and the time to first bowel movement after surgery were recorded.ResultsThere were no significant differences in demographic and clinical characteristics between the H group and the E group. There were no significant differences in FLACC scores at postoperative 0, 2, 6, 12, 24, 36, and 48 h in intra-group and inter-group comparisons. There were no significant differences in Ramsay sedation scores at postoperative 0, 2, 6, 12, 24, 36, and 48 h in the intra-group comparisons. Ramsay sedation scores were significantly lower at postoperative 2, 12, and 36 h in the H group compared to the E group. There were no significant differences in the PAED scale or incidence of nausea and vomiting or pruritus between the H group and the E group. The incidence of hypotension and respiratory depression was significantly lower, and the time to first bowel movement was significantly shorter in the E group compared to the H group. Urinary tryptophan, 5-hydroxytryptamine and substance P levels were significantly lower but arginine was significantly higher in the E group compared to the H group.ConclusionsThe combination of continuous intravenous infusion of esketamine with sacral block provided safe and effective postoperative analgesia for pediatric patients undergoing surgery for hypospadias.Trial registrationChinese Clinical Trial Register ChiCTR2200066967. Clinical trial registry URL: http://www.chictr.org.cn/edit.aspx?pid=185042&htm=4

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Section: Discussionmentioning

confidence: 99%

Safety and efficacy of esketamine for postoperative analgesia in pediatric patients with hypospadias

Chen²,

Li³

et al. 2023

Front. Surg.

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Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)

et al. 2021

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Introduction Postoperative pain remains incompletely controlled for decades. Recently, multimodal analgesia is emerging as a potential approach in the management of postoperative pain. Therein, S(+)-ketamine is appealing as an adjuvant drug in multimodal analgesia due to its unique pharmacological advantages. This pragmatic clinical trial (SAFE-SK-A trial) is designed to investigate the analgesic effect and safety of S(+)-ketamine for acute postoperative pain in adults and explore the optimal strategy of perioperative intravenous S(+)-ketamine in a real-world setting. Methods and analysis This multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A study) is planned to conduct in 80 centres from China and recruit a total of 12 000 adult participants undergoing a surgical procedure under general anaesthesia. Patient recruitment started in June 2021 and will end in June 2022. Participants will be randomised in a ratio of 2:1 to either receive perioperative intravenous S(+)-ketamine plus conventional anaesthesia or conventional anaesthesia only. Given the pragmatic nature of the study, no specific restriction as to the administration dosage, route, time, synergistic regimen or basic analgesics. Primary endpoints are the area under the broken line of Numerical Rating Scale (NRS) scores for pain intensity and the total opioid consumption within 48 hours postoperative. Secondary endpoints are postoperative NRS scores, the anaesthesia recovery time, time of first rescue analgesia, the incidence of rescue analgesia, the incidence of postoperative delirium, patient questionnaire for effect, changes from baseline in cognitive function and anxiety and depression, as well as the adverse events and pharmacoeconomic outcomes. The general linear model will be used for the primary endpoint, and appropriate methods will be used for the secondary endpoints. Ethics and dissemination This trial has been approved by the local Institutional Review Board (S2021-026-02) and conducted following the Declaration of Helsinki. Results of this trial will be publicly disclosed and published in scientific journals. Trial registration number NCT04837170; Pre-results.

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Assessing the effectiveness of perioperative s-ketamine on new-onset headache after resective epilepsy surgery (ESPAIN-trial): protocol for a randomised, double-blind, placebo-controlled trial

Cited by 2 publications

References 29 publications

Safety and efficacy of esketamine for postoperative analgesia in pediatric patients with hypospadias

Safety and efficacy of esketamine for postoperative analgesia in pediatric patients with hypospadias

Perioperative intravenous S(+)-ketamine for acute postoperative pain in adults: study protocol for a multicentre, randomised, open-label, positive-controlled, pragmatic clinical trial (SAFE-SK-A trial)

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