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

Autor: Albert Colon, Sander M. J. van Kuijk, Olaf E. M. G. Schijns, Rob P.W. Rouhl, Govert Hoogland, Jim Dings, Michael J Bos, Jiske Cornelia Theresa Sloekers, Maurice Theunissen, Kim Rijkers, Caroline H. G. Bastiaenen
Přispěvatelé: RS: MHeNs - R3 - Neuroscience, Neurochirurgie, MUMC+: MA Anesthesiologie (9), MUMC+: MA Niet Med Staf Neurochirurgie (9), RS: CAPHRI School for Public Health and Primary Care, RS: CAPHRI - R3 - Functioning, Participating and Rehabilitation, Epidemiologie, RS: CAPHRI - R2 - Creating Value-Based Health Care, MUMC+: KIO Kemta (9), MUMC+: MA Med Staf Spec Neurochirurgie (9), Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience
Rok vydání: 2019
Předmět:
medicine.medical_specialty
medicine.medical_treatment
Placebo-controlled study
Placebo
s-ketamine
Neurosurgical Procedures
Perioperative Care
Anaesthesia
03 medical and health sciences
drug-resistant epilepsy
0302 clinical medicine
Double-Blind Method
030202 anesthesiology
Protocol
Humans
Medicine
General anaesthesia
Epilepsy surgery
Adverse effect
Anterior temporal lobectomy
Acetaminophen
Randomized Controlled Trials as Topic
Pain
Postoperative
Epilepsy
business.industry
Headache
Amygdalohippocampectomy
opioids
General Medicine
Perioperative
Analgesics
Non-Narcotic
temporal lobe epilepsy
DIAGNOSTIC QUESTIONNAIRE
Analgesics
Opioid
Drug Combinations
postcraniotomy headache
Treatment Outcome
POSTOPERATIVE PAIN
CRANIOTOMY
epilepsy surgery
Physical therapy
Ketamine
business
030217 neurology & neurosurgery
Zdroj: BMJ Open, 9(8):e030580. BMJ Publishing Group
BMJ Open
ISSN: 2044-6055
DOI: 10.1136/bmjopen-2019-030580
Popis: IntroductionEffective treatment of new-onset headache after craniotomy, especially anterior temporal lobectomy (ATL) and amygdalohippocampectomy for drug-resistant temporal lobe epilepsy, is a challenge. The current practice, acetaminophen combined with opioids is often reported by patients as insufficient and sometimes accompanied by opioid-related adverse effects. Based on expert opinion, anaesthesiologists therefore frequently consider s-ketamine as add-on therapy. This randomised parallel group design trial compares s-ketamine with a placebo as add on medication to a multimodal pain approach.Methods and analysisIn total 62 adult participants, undergoing ATL for drug resistant epilepsy under general anaesthesia, will be randomised to either receive a 0.25 mg/kg bolus followed by a continuous infusion of 0.1 mg/kg/hour of s-ketamine or placebo (0.9% NaCl) starting before incision and continued for 48 hours as an addition to acetaminophen and opioids administered in a patient-controlled analgesia pump. The primary outcome measure is the cumulative postoperative opioid consumption. Patient recruitment started August 2018 and will end in 2021. Secondary outcome measures are postoperative pain intensity scores, psychological parameters, length of hospital stay and adverse events and will be reassessed at 3 and 6 months after surgery, with a baseline measurement preoperatively. All data are collected by researchers who are blinded to the treatment. The data will be analysed by multivariable linear mixed-effects regression.Ethics and disseminationEthical approval has been given by the local medical ethical committee (NL61666.068.17). This study will be conducted in accordance with the Dutch Medical Research Involving Human Subjects Act and the Declaration of Helsinki. The results of this trial will be publicly disclosed and submitted for publication in an international peer-reviewed scientific journal.Trial registration numberNTR6480.
Databáze: OpenAIRE
Externí odkaz: