Oral ketamine for children with chronic pain: a pilot phase 1 study.
Ontology highlight
ABSTRACT: Objective
To assess whether oral ketamine is safe at higher dosages for sedating children and whether it may be an option for the control of chronic pain in children.Study design
A prospective study was performed on 12 children with chronic pain to identify the maximum tolerated dosage of oral ketamine. Participants were given 14 days of oral ketamine, 3 times daily, at dosages ranging from 0.25-1.5 mg/kg/dose. Participants were assessed for toxicity and for pain severity at baseline and on day 14 of treatment.Results
Two participants, both treated at 1.5 mg/kg/dose, experienced dose-limiting toxicities (sedation and anorexia). One participant, treated at 1 mg/kg/dose, opted to stop ketamine treatment due to new pain on treatment. Nine participants completed their course of ketamine treatment. Of these 12 children, 5 experienced improvement in their pain scores, 2 with complete resolution of pain, lasting >4 weeks off ketamine treatment.Conclusion
Oral ketamine at dosages of 0.25-1 mg/kg/dose appears to be safe when given for 14 days to children with chronic pain.
SUBMITTER: Bredlau AL
PROVIDER: S-EPMC3799772 | biostudies-literature | 2013 Jul
REPOSITORIES: biostudies-literature
Similar Datasets
Project description:Ketamine has received attention recently as an agent for chronic pain. There are concerns, however, regarding the neurocognitive changes patients might experience after ketamine exposure. This prospective, uncontrolled study describes the neurocognitive functioning of 11 children with chronic pain before and after 2 weeks of daily oral ketamine exposure. Neurocognitive assessment was performed at baseline, Week 2, and Week 14. We hypothesized that there would be declines in neurocognitive scores at either Week 2 or Week 14. No decline in neurocognitive function was detected in the children investigated. Mean scores for tests measuring executive function and memory were improved at Weeks 2 and 14 compared to baseline. This study did not detect any decline in neurocognitive scores in a small number of children exposed to 2 weeks of oral ketamine therapy. Randomized, controlled studies of the neurocognitive effects of ketamine in children are recommended to further investigate these preliminary findings.
| S-EPMC4618408 | biostudies-literature
Project description:Mucositis is a significant complication of intensive chemotherapy or hematopoietic cell transplantation (HCT), with few treatment options. Ketamine mouthwashes have been used for pain relief, but supporting evidence is limited. The primary objective of this study was to assess the reduction in pain intensity of stomatodynia and odynophagia compared to baseline assessment.This open-label, prospective, phase II interventional study (NCT01566448) was conducted from February 2012 through July 2015. Patients with grade 3 or 4 oral mucositis according to the World Health Organization (WHO) scale as a result of chemotherapy were treated with ketamine mouthwash 20 mg/5 mL four times daily and every 4 h as needed.Thirty patients were enrolled and a total of 136 assessments were conducted. A statistically significant reduction in pain scores of 2 and 3 points was achieved after 1 h and 3 days, respectively (p < 0.0001, p = 0.0003). Pain scores were significantly improved while swallowing, reduced 1 and 4 points at 1-h and 3-day assessment, respectively (p = 0.0006, p = 0.0001). No patients developed adverse effects related to ketamine administration.Ketamine mouthwashes resulted in clinically meaningful and statistically significant reduction in pain scores, have an acceptable safety profile, and can be a useful adjunctive treatment in the multi-modal management of severe mucositis.
| S-EPMC5500907 | biostudies-literature
Project description:Introduction: Pelvic pain is a common problem in gynaecological practice. It is often unclear whether definite causality exists between reported symptoms and objective clinical findings of the female genital tract, and medical or operative treatments do not always achieve long-term resolution of symptoms. Methods: This pilot study investigated 28 patients (age 20-65, median 36.5 years) from a gynaecology practice whose only clinical finding was painful pelvic floor muscle tightness. Following standardised gynaecological and physiotherapist examination, all patients received osteopathic treatment. Pain had been present for a median of 3 years (range 1 month to 20 years). 14 patients had previously confirmed endometriosis. Treatment success was evaluated on consultation with patients in person or in writing. Results: 22 of the 28 participants completed the treatment according to plan. Overall, 17 reported symptom improvement, while 10 of the 14 patients with endometriosis did. Conclusion: Osteopathy is well received by women with painful pelvic floor muscle tightness and appears to be an effective treatment option.
| S-EPMC5033650 | biostudies-literature
Project description:The long-term effects of opioids on sensitization processes are believed to be mediated through the N-methyl-D-aspartate receptor. Quantitative sensory testing (QST) changes observed after a ketamine infusion have been previously described but the effect that chronic opioids will have is not known. The results of this prospective randomized factorial trial compared the thermal QST changes observed after a .05 mg/kg ketamine infusion or a saline placebo in chronic pain subjects who were either opioid-naive or were chronically using opioids for chronic noncancer pain are presented. No baseline QST differences were noted between the 4 groups at baseline. Comparison of changes preinfusion with postinfusion QST measurements resulted in decreased average change in temporal summation response between opioid subjects who received a placebo compared with those who received a ketamine infusion (-5.22, SD = 9.96 vs 13.81, SD = 19.55; P = .004). Additionally, the average change in temporal summation was decreased among subjects who received a ketamine infusion and were not chronically using opioids compared with subjects who were using chronic opioids and received a placebo infusion (-1.91, SD = 13.25 vs 13.81, SD = 19.55; P = .007). The results indicate that low-dose ketamine infusions produce subtle changes in QST phenotypes that are modified by the chronic use of opioids. This illustrates the potential diagnostic and therapeutic value of ketamine in the setting of chronic opioid use. PERSPECTIVE:The presented data further our understanding of modulation of sensory perception in the setting of chronic opioid use and the role of the N-methyl-D-aspartate receptor. The use of low-dose ketamine infusions may be useful for the treatment as well as diagnosis of opioid-related neuropathic conditions.
| S-EPMC5729746 | biostudies-literature
Project description:This article explores the effectiveness of a newly developed Pain Neuroscience Education program for children (PNE4Kids) with functional abdominal pain disorder (FAPD). Children (6-12 years) with FAPD were randomly assigned to 1) the experimental group (n = 14), participating in one hypnotherapy session (i.e., usual care) and one additional PNE4Kids session, or 2) the control group (n = 14), participating in two hypnotherapy sessions. Parental pain catastrophizing, the child's functional disability (parental-proxy), pain-related fear (parent-proxy) and pain intensity, were assessed at baseline and one and three weeks after each therapy session. Pressure algometry and a conditioned pain modulation paradigm were performed at baseline and three weeks after completion of the last therapy session. Parents from both the experimental as well as the control group showed significantly less parental pain catastrophizing (p < 0.01). Children showed significantly less functional disability (p < 0.05), pain-related fear (p < 0.01) and local pressure pain sensitivity (p < 0.05) at short-term follow-up (three weeks after last intervention) in both groups. No significant (p > 0.05) between-group differences were found. Hypnotherapy combined with PNE4Kids did not result in better clinical outcomes compared to hypnotherapy alone. Study limitations include the application of one single PNE4Kids session and the short follow-up time.
| S-EPMC7356615 | biostudies-literature
Project description:BackgroundChronic pain is estimated to impact one-in-three children with cerebral palsy (CP). Psychological interventions including behavioral and cognitive strategies play a key role in chronic pain management, but there is a paucity of research exploring their use in children with CP.AimTo investigate the acceptability and feasibility of biofeedback assisted relaxation training (BART) for chronic pain management in children with CP using a mixed-methods study design.MethodsBiofeedback assisted relaxation training was delivered via BrightHearts, an iOS application. Inclusion criteria were as follows: CP; self-reported chronic pain; age 9-18 years; and fluent English speaker. Children used BrightHearts for ten minutes daily, over four weeks. Qualitative post-intervention interviews were undertaken (child, parent) and quantitative pre-post measures (child) were gathered including pain intensity (numerical rating scale), and anxiety intensity (numerical rating scale). Content analysis was conducted for qualitative data. Descriptive statistics and exploratory analyses were performed for quantitative data.ResultsTen children participated (n = 3 male, mean age = 13.1 years SD = 2.5 years, GMFCS level I = 4, II = 2, III = 3, IV = 1). Predominant movement disorder was spasticity (n = 7) and dyskinesia, mainly dystonia (n = 3). Content analysis suggested an overarching theme "BrightHearts is a good thing to put in my toolbox" providing an overall representation of participants' experiences. For many, BrightHearts was a valuable supplement to children's pain management strategies: "The source of the pain is still there, but the actual effect of the pain isn't so relevant." Four sub-themes were identified: "Managing my pain;" "Managing my anxiety and stress," "Helping me do what I need to do;" and "Fitting it into my life." Some participants reported improvements in their anxiety management, and others described benefits in sleep and school following improved pain/anxiety management. A range of practical and personal factors within this heterogeneous group presented barriers to using BrightHearts including limited time, attention, and boredom. Seven-out-of-eight children would recommend BrightHearts to others with chronic pain and six-out-of-eight noticed a difference in their pain since using BrightHearts (n = 2 missing data). Non-significant reductions in pain or anxiety intensity scores were found following the intervention.ConclusionThis pilot suggests BrightHearts is an acceptable and feasible intervention for chronic pain management in children with CP and may be useful for some children as part of a multimodal approach.
| S-EPMC8975200 | biostudies-literature
Project description:ObjectivesThere has been controversy over whether ketamine affects intracranial pressure (ICP) in children. Transcranial Doppler ultrasound (TCD) is a validated technique used to assess ICP changes noninvasively. Gosling pulsatility index (PI) directly correlates with ICP changes. The objective of this study was to quantify PI changes as a surrogate marker for ICP changes in previously healthy children receiving intravenous ketamine for procedural sedation.MethodsWe performed a prospective, observational study of patients 5-18 years old who underwent sedation with intravenous ketamine as monotherapy. ICP changes were assessed by surrogate PI at baseline, immediately after ketamine administration, and every 5 minutes until completion of the procedure. The primary outcome measure was PI change after ketamine administration compared to baseline (denoted ΔPI).ResultsWe enrolled 15 participants. Mean age was 9.9 ± 3.4 years. Most participants underwent sedation for fracture reduction (87%). Mean initial ketamine dose was 1.4 ± 0.3 mg/kg. PI decreased at all time points after ketamine administration. Mean ΔPI at sedation onset was -0.23 (95% confidence interval [CI] = -0.30 to -0.15), at 5 minutes was -0.23 (95% CI = -0.28 to -0.18), at 10 minutes was -0.14 (95% CI = -0.21 to -0.08), at 15 minutes was -0.18 (95% CI = -0.25 to -0.12), and at 20 minutes was -0.19 (95% CI = -0.26 to -0.12). Using a clinically relevant threshold of ΔPI set at +1 (+8 cm H2O), no elevation in ICP, based on the PI surrogate marker, was demonstrated with 95% confidence at all time points after ketamine administration.ConclusionsKetamine did not significantly increase PI, which was used as a surrogate marker for ICP in this sample of previously healthy children. This pilot study demonstrates a model for evaluating ICP changes noninvasively in the emergency department.
| S-EPMC9292470 | biostudies-literature
Project description:Background and objectivesThe goal of this meta-analysis study was to perform a systematic review of the literature on the effects of ketamine on postoperative pain following tonsillectomy and adverse effects in children.Subjects and methodsTwo authors independently searched three databases (MEDLINE, SCOPUS, Cochrane) from their inception of article collection to February 2014. Studies that compared preoperative ketamine administration (ketamine groups) with no treatment (control group) or opioid administration (opioid group) where the outcomes of interest were postoperative pain intensity, rescue analgesic consumption, or adverse effects (sedation, nausea and vomiting, bad dream, worsening sleep pattern, and hallucination) 0-24 hours after leaving the operation room were included in the analysis.ResultsThe pain score reported by the physician during first 4 hours and need for analgesics during 24 hours postoperatively was significantly decreased in the ketamine group versus control group and was similar with the opioid group. In addition, there was no significant difference between ketamine and control groups for adverse effects during 24 hours postoperatively. In the subgroup analyses (systemic and local administration) regarding pain related measurements, peritonsillar infiltration of ketamine was more effective in reducing the postoperative pain severity and need for analgesics.ConclusionPreoperative administration of ketamine systemically or locally could provide pain relief without side-effects in children undergoing tonsillectomy. However, considering the insufficient evaluation of efficacy of ketamine according to the administration methods and high heterogeneity in some parameters, further clinical trials with robust research methodology should be conducted to confirm the results of this study.
| S-EPMC4076328 | biostudies-literature
Project description: Not available
| S-EPMC1867894 | biostudies-literature
Project description:BackgroundThe modern management of chronic pain is largely focused on improving functional capacity (often despite ongoing pain) by using graded activation and exposure paradigms. However, many people with chronic pain find functional activation programs aversive, and dropout rates are high. Modern technologies such as virtual reality (VR) could provide a more enjoyable and less threatening way for people with chronic pain to engage in physical activity. Although VR has been successfully used for pain relief in acute and chronic pain settings, as well as to facilitate rehabilitation in conditions such as stroke and cerebral palsy, it is not known whether VR can also be used to improve functional outcomes in people with chronic pain.ObjectiveThis study aimed to assess the feasibility of conducting an adequately powered randomized controlled trial (RCT) to test the efficacy of VR in a chronic pain treatment center and assess the acceptability of an active VR treatment program for patients in this setting.MethodsFor this mixed methods pilot study, which was designed to test the feasibility and acceptability of the proposed study methods, 29 people seeking treatment for chronic pain were randomized to an active VR intervention or physiotherapy treatment as usual (TAU). The TAU group completed a 6-week waitlist before receiving standard treatment to act as a no-treatment control group. The VR intervention comprised twice-weekly immersive and embodied VR sessions using commercially available gaming software, which was selected to encourage movement. A total of 7 VR participants completed semistructured interviews to assess their perception of the intervention.ResultsOf the 99 patients referred to physiotherapy, 53 (54%) were eligible, 29 (29%) enrolled, and 17 (17%) completed the trial, indicating that running an adequately powered RCT in this setting would not be feasible. Despite this, those in the VR group showed greater improvements in activity levels, pain intensity, and pain interference and reported greater treatment satisfaction and perceived improvement than both the waitlist and TAU groups. Relative effect sizes were larger when VR was compared with the waitlist (range small to very large) and smaller when VR was compared with TAU (range none to medium). The qualitative analysis produced the following three themes: VR is an enjoyable alternative to traditional physiotherapy, VR has functional and psychological benefits despite continued pain, and a well-designed VR setup is important.ConclusionsThe active VR intervention in this study was highly acceptable to participants, produced favorable effects when compared with the waitlist, and showed similar outcomes as those of TAU. These findings suggest that a confirmatory RCT is warranted; however, substantial barriers to recruitment indicate that incentivizing participation and using a different treatment setting or running a multicenter trial are needed.
| S-EPMC9330488 | biostudies-literature