Safety and efficacy of two protocols for sedation in pediatric oncology procedures

Open Medicine ◽  
2008 ◽  
Vol 3 (1) ◽  
pp. 77-82 ◽  
Author(s):  
Francesca Crea ◽  
Antonio Ruggiero ◽  
Orazio Genovese ◽  
Luca Tortorolo ◽  
Giulia Zorzi ◽  
...  
Keyword(s):  
Side Effects ◽  
Lumbar Puncture ◽  
Lymphoblastic Leukemia ◽  
Invasive Procedures ◽  
Safety And Efficacy ◽  
Pain Scores ◽  
Significant Difference ◽  
Sedation Scores ◽  
Sedation And Analgesia ◽  
Vital Parameters

AbstractInvasive procedures, such as the lumbar puncture, can cause anxiety and pain in children undergoing treatment for acute lymphoblastic leukemia (ALL). We investigated the safety and efficacy of two different protocols for pain relief in 20 children with ALL undergoing lumbar puncture. Protocol A was composed of an association between propofol and alfentanil. Protocol B consisted in the combination of propofol and ketamine. Vital and behavioural parameters, sedation and pain scores were recorded at different times during and after the procedure. All patients showed a satisfactory sedation and analgesia. We found a statistically significant difference of vital parameters between protocol A and protocol B, while there were no significative differences between sedation scores and the other parameters evaluated. Patients in protocol A showed a higher incidence of major side effects, such as respiratory depression. Our results show that both protocols are effective to obtain a good sedation and analgesia in children with ALL undergoing lumbar puncture, but the association between propofol and ketamine appears more safe due to the lower incidence of side effects.

scholarly journals The Effects of Single-Dose Rectal Midazolam Application on Postoperative Recovery, Sedation, and Analgesia in Children Given Caudal Anesthesia Plus Bupivacaine

2014 ◽  
Vol 2014 ◽  
pp. 1-6
Author(s):  
Sedat Saylan ◽  
Ahmet Eroglu ◽  
Davut Dohman
Keyword(s):  
Adverse Effects ◽  
Pain Scale ◽  
Postoperative Recovery ◽  
Preoperative Period ◽  
Sedation Scale ◽  
Caudal Block ◽  
Caudal Anesthesia ◽  
Significant Difference ◽  
Sedation Scores ◽  
Sedation And Analgesia

Background. This study aimed to compare the effects of rectal midazolam addition after applying bupivacaine and caudal anesthesia on postoperative analgesia time, the need for additional analgesics, postoperative recovery, and sedation and to find out its adverse effects in children having lower abdominal surgery.Methods. 40 children between 2 and 10 years of ASA I-II were randomized, and they received caudal anesthesia under general anesthesia. Patients underwent the application of caudal block in addition to saline and 1 mL/kg bupivacaine 0.25%. In the postoperative period, Group C (n= 20) was given 5 mL saline, and Group M (n= 20) was given 0.30 mg/kg rectal midazolam diluted with 5 mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.Results. Demographic and hemodynamic data of the two groups did not differ. Postoperative sedation scores in both groups were significantly lower compared with the preoperative period. There was no significant difference between the groups in terms of sedation and sufficient analgesia.Conclusions. We conclude that caudal anesthesia provided sufficient analgesia in peroperative and postoperative periods, and rectal midazolam addition did not create any differences. This trial is registered with ClinicalTrials.govNCT02127489.

Prognostic Significance of Blasts in the Cerebrospinal Fluid Without Pleiocytosis or a Traumatic Lumbar Puncture in Children With Acute Lymphoblastic Leukemia: Experience of the Dutch Childhood Oncology Group

2006 ◽  
Vol 24 (15) ◽  
pp. 2332-2336 ◽  
Author(s):  
D. Maroeska W.M. te Loo ◽  
Willem A. Kamps ◽  
Anna van der Does-van den Berg ◽  
Elisabeth R. van Wering ◽  
Siebold S.N. de Graaf
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Lumbar Puncture ◽  
Cox Regression ◽  
Lymphoblastic Leukemia ◽  
Prognostic Significance ◽  
Event Free Survival ◽  
Free Survival ◽  
Cox Regression Analysis ◽  
Significant Difference

Purpose To determine the significance of blasts in the CSF without pleiocytosis and a traumatic lumbar puncture in children with acute lymphoblastic leukemia (ALL). Patients and Methods We retrospectively studied a cohort of 526 patients treated in accordance with the virtually identical Dutch protocols ALL-7 and ALL-8. Patients were classified into five groups: CNS1, no blasts in the CSF cytospin; CNS2, blasts present in the cytospin, but leukocytes less than 5/μL; CNS3, blasts present and leukocytes more than 5/μL. Patients with a traumatic lumbar puncture (TLP; > 10 erythrocytes/mL) were classified as TLP+ (blasts present in the cytospin) or TLP− (no blasts). Results Median duration of follow-up was 13.2 years (range, 6.9 to 15.5 years). Event-free survival (EFS) was 72.6% (SE, 2.5%) for CNS1 patients (n = 304), 70.3% (SE, 4.7%) for CNS2 patients (n = 111), and 66.7% (SE, 19%) for CNS3 patients (n = 10; no significant difference in EFS between the groups). EFS was 58% (SE, 7.6%) for TLP+ patients (n = 62) and 82% (SE, 5.2%) for TLP− patients (n = 39; P < .01). Cox regression analysis identified TLP+ status as an independent prognostic factor (risk ratio, 3.5; 95% CI, 1.4 to 8.8; P = .007). Cumulative incidence of CNS relapses was 0.05 and 0.07 in CNS1 and CNS2 patients, respectively (not statistically significant). Conclusion In our experience, the presence of a low number of blasts in the CSF without pleiocytosis has no prognostic significance. In contrast, a traumatic lumbar puncture with blasts in the CSF specimen is associated with an inferior outcome.

scholarly journals Intramuscular Ketorolac for Postoperative Analgesia following Laparoscopic Sterilisation

1994 ◽  
Vol 22 (1) ◽  
pp. 22-24 ◽  
Author(s):  
M. H. Shapiro ◽  
B. L. Duffy
Keyword(s):  
Side Effects ◽  
Intramuscular Injection ◽  
Double Blind Study ◽  
Day Case ◽  
Double Blind ◽  
Apparent Lack ◽  
Pain Scores ◽  
Significant Difference ◽  
To Receive ◽  
Intramuscular Ketorolac

The analgesic effect of intramuscular ketorolac was assessed by double blind study in forty women presenting for day-case laparoscopic sterilisation. The patients were randomly allocated to receive either ketorolac 30 mg or saline by intramuscular injection immediately following induction of general anaesthesia. There was no statistically significant difference between the groups in pain scores, opioid requirements or incidence of nausea and vomiting in the postoperative period. In view of the potential side-effects of ketorolac, and the apparent lack of efficacy when used prophylactically, the routine use of the drug in this group of patients cannot be recommended.

scholarly journals Perioperative Intravenous Low-Dose Ketamine Infusion to Minimize Pain for Septorhinoplasty: A Prospective, Randomized, Double-Blind Study

2020 ◽  
pp. 014556132097486
Author(s):  
Irem Ates ◽  
Muhammed Enes Aydin ◽  
Erkan Cem Celik ◽  
Mustafa Sitki Gozeler ◽  
Ali Ahiskalioglu
Keyword(s):  
Side Effects ◽  
Low Dose ◽  
Blind Study ◽  
Control Group ◽  
Anesthesia Induction ◽  
Double Blind Study ◽  
Double Blind ◽  
Ketamine Infusion ◽  
Pain Scores ◽  
Significant Difference

Objectives: Studies investigating the effects of intravenous (IV) ketamine in pain management after septorhinoplasty is limited. This study aims to evaluate the efficacy of low-dose IV infusion of ketamine on pain scores. Methods: This randomized, prospective, double-blind study was conducted with 48 patients who underwent septorhinoplasty. Intravenous ketamine bolus (0.5 mg/kg) was administered to the ketamine group (group K, n = 24) at anesthesia induction, and ketamine infusion was continued (0.25 mg/kg/h) during the surgery. In the control group (group C, n = 24), the same protocol was administered using saline instead of ketamine. Furthermore, 50-mg dexketoprofen trometamol was administered to both groups 30 minutes before the end of the surgery. Then it was repeated at the 12th and 24th hours postoperatively. Pain scores were evaluated with the visual analogue scale. Consumptions intraoperative of opioid and sevoflurane, rescue opioid requirement, patient satisfaction, and side effects were recorded. Results: Pain scores were significantly lower in group K at all postoperative periods ( P < .05). There was no significant difference between the groups in terms of intraoperative sevoflurane and remifentanil consumptions ( P > .05). Rescue opioid analgesic requirements were significantly lower in group K than group C (0/24 vs 6/24, respectively; P  = .022). Side effects were similar between the groups ( P > .05). Conclusion: We recommend the administration of low-dose ketamine infusion during septorhinoplasty surgery because it reduces the requirement for rescue opioid analgesia and postoperative pain scores.

Clofarabine in the Frontline Treatment of Childhood Acute Lymphoblastic Leukemia. Results of the COALL 08–09 Study Regarding Safety and Efficacy of Clofarabine in Combination with Asparaginase During Consolidation Therapy.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2606-2606
Author(s):  
Gabriele Escherich ◽  
Martin Zimmermann ◽  
Martin A. Horstmann
Keyword(s):  
Acute Lymphoblastic Leukemia ◽  
Side Effects ◽  
High Risk ◽  
Lymphoblastic Leukemia ◽  
Historical Control ◽  
High Dose ◽  
Consolidation Therapy ◽  
Safety And Efficacy ◽  
High Dose Cytarabine ◽  
Grade 3

Abstract Abstract 2606 Background Since the FDA approval for clofarabine in the treatment of childhood relapsed or refractory acute lymphoblastic leukemia (ALL) several studies have been launched which put clofarabine under scrutiny in combination with other cytostatic drugs as second or third line therapy. As a novel treatment strategy we introduced the combination of clofarabine with asparaginase into the frontline management of ALL. To assess safety and efficacy of clofarabine in combination with PEG-ASP, high risk B- progenitor and T-ALL patients received this regimen as a postinduction treatment within the CoALL 08–09 protocol. Patients and methods In October 2010 the CoALL trial 08–09 was opened for enrollment of patients under 18 years with confirmed diagnosis of acute B-progenitor or T-cell leukemia. Until December 2011 109 patients were accrued as study patients. Patients being identified for a high risk of relapse by PCR based MRD at the end of induction were stratified to receive the combination of clofarabine 5 × 40 mg/m2 and pegylated asparaginase (PEG-ASP) 2.500 IU/m2 at the beginning of consolidation therapy. Criteria for eligibility were cytomorphologic remission and an MRD load ≥ 10−4for B-progenitor patients and a MRD load ≥ 10−3 at day 43, after they had already received one cyclophosphamide and methotrexate containing consolidation cycle for T-ALL patients. All other patients received the standard treatment of high dose cytarabine 4 × 3g/m2(HIDAC) in combination with PEG-ASP 2.500 IU/m2. For comparison a historical control cohort from the predecessor CoALL 07-03 trial were analyzed who fulfilled the same MRD criteria. In this trial all patients received the standard postinduction therapy with high dose cytarabine and asparaginase. Results Forty-two out of 109 patients of the CoALL 08–09 trial (39 B-progenitor and 3 T-ALL) fulfilled the inclusion criteria, were stratified and received the clofarabine/PEG-ASP treatment. No unknown or unexpected severe side effects were observed after the treatment of clofarabine with PEG-ASP. No grade 3 or 4 skin, central or peripheral neurological or renal toxicity occurred. In 13/42 patients grade 3 and in 6/42 patients grade 4 elevation of transaminases were reported, which were all reversible. There was a remarkable response to the treatment of clofarabine/PEG-ASP measured by MRD. In comparative analysis the MRD response to clofarabine/PEG-ASP was superior to that reached after HIDAC/PEG-ASP as it is shown in Figure 1. A logistic regression analysis of the MRD response with the MRD level at end of induction as covariable showed an odds ratio of 0.26 (95% CI 0.9-0.8, p=0.02) for clofarabine vs HIDAC. Conclusion In this cohort of high risk ALL patients clofarabine in combination with PEG-ASP given as the first postinduction treatment in the frontline management of acute lymphoblastic leukemia was well tolerated without severe or persistent side effects. Moreover, the antileukemic effect of this combination appears to be superior compared to the historical control group treated with high dose cytarabine and PEG-ASP at the same time point of treatment which warrants further investigation in a randomized fashion. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Pilot study of orphenadrine as a novel treatment for muscle cramps in patients with liver cirrhosis

2017 ◽  
Vol 6 (3) ◽  
pp. 422-427 ◽  
Author(s):  
Sherief Abd-Elsalam ◽  
Ferial El-Kalla ◽  
Lobna A Ali ◽  
Samah Mosaad ◽  
Walaa Alkhalawany ◽  
...  
Keyword(s):  
Liver Cirrhosis ◽  
Side Effects ◽  
Safety And Efficacy ◽  
Muscle Cramps ◽  
Novel Treatment ◽  
Significant Difference ◽  
Before And After ◽  
Cirrhotic Patients ◽  
To Receive

Background and aims Muscle cramps markedly affect the quality of life in cirrhotic patients with no available highly effective treatment. The aim of this study was to assess the safety and efficacy of orphenadrine in the treatment of muscle cramps in cirrhotic patients. Methods The study enrolled 30 liver cirrhosis patients complaining of frequent muscle cramps (≥3 per week), who were randomized to receive either orphenadrine 100 mg or calcium carbonate 500 mg twice daily as a control for one month. Severity, frequency, and duration of the muscle cramps were assessed before and after treatment as well as recurrence after washout of the drug for two weeks. Side effects were recorded. Results One month after treatment with orphenadrine; the frequency of muscle cramps decreased significantly to 0.6 ± 0.74 per week compared to 12.53 ± 6.01 at baseline ( p < 0.001), the duration of muscle cramps decreased from 1 min to 0.1 min after treatment ( p < 0.001). The pain score improved significantly from a score of 8/10 to 0/10 ( p < 0.001). The side effects were few, such as dry mouth, drowsiness, and nausea, with no significant difference between their occurrences in the two groups. Conclusion Orphenadrine is safe and effective in treatment of muscle cramps in patients with liver cirrhosis.

scholarly journals A comparison of propofol with ketofol for sedation quality and side effects in patients undergoing colonoscopy.

2021 ◽  
Vol 38 (SI-1) ◽  
pp. 65-70
Author(s):  
Ender ÇAM ◽  
Sibel BARİS ◽  
Deniz KARAKAYA
Keyword(s):  
Side Effects ◽  
Recovery Room ◽  
Age Groups ◽  
Injection Pain ◽  
Sedation Level ◽  
Positive Effects ◽  
Endoscopic Method ◽  
Respiratory Parameters ◽  
Significant Difference ◽  
Vital Parameters

Colonoscopy is an endoscopic method and ıt is better to perform this procedure under sedoanalgesia in order to eliminate patients’ anxiety, the colic-like pain and discomfort that occur during the procedure [1]. The aim of this study was to compare the effects of propofol and propofol+ketamine (ketofol) on sedation and side effects in patients undergoing colonoscopy. Material-Method: 50 patients with ASA I-II that are between the ages of 18-65. The patients in the propofol group and Ketofol group were given 0.1mL/kg of drug and/or combination of drugs. The vital parameters, injection pain, spontaneous time of opening eyes, the time of Modified Aldrete Score (MAS) ≥ 9 and the amount of medication used during the procedure and in the recovery room were recorded. Results: There was no significant difference between the two groups during the procedure and in the recovery room (p<0.05). It was shown that the ketamine reduces the amount of propofol by 50% and propofol induced injection pain. Ketofol had no positive effects on hemodynamic and respiratory parameters. Conclusion: We assert that the ratio of combinations will vary depending on the necessary sedation level and analgesic need of the procedure to be performed and depending on the frequency of the administration of additional doses. Although ketofol is being used in different procedures and different age groups in the recent years, there is still need for studies conducted with different drug dosages of this combination.

scholarly journals Comparison of Efficacy and Safety of Patient Taking Pregabalin and Desvenlafaxine in Neuropathic Pain

2020 ◽  
Vol 5 (8) ◽  
pp. 231-235
Author(s):  
Neenu Rachel Santhosh ◽  
Ajay K Raj ◽  
Rahmathullah SN ◽  
Dr.Abdu Rahman ◽  
Sereena A
Keyword(s):  
Neuropathic Pain ◽  
Side Effects ◽  
Pain Relief ◽  
Observational Study ◽  
Prospective Observational Study ◽  
Efficacy And Safety ◽  
Safety And Efficacy ◽  
Visual Analogue Pain ◽  
Pain Scores ◽  
Prolonged Pain

To compare safety and efficacy of pregabalin and desvenlafaxine respectively for treating Neuropathic Pain. 04 patients were entered into a prospective observational study of pregabalin and desvenlafaxine in neuropathic pain for 6 months. Patients were randomly arranged into 2 groups, 52 patients received pregabalin and other group of 52 patients received desvenlafaxine. The initialassessement were made during the first visit and two subsequent reviews were done in 2 months interval, up to 6 months. Visual analogue pain scores, incidence of side effects were measured. The pain scores(mean±S.D.) were 5.37±1.14 and 6.7±1.39 respectively for desvenlafaxine and pregabalin.The low pain score of desvenlafaxine was associated with prolonged pain relief. There were pronounced differences in incidence of side effect between the two drugs: pregabalin, 36.5% compared to desvenlafaxine, 7%. The study findings revealed that desvenlafaxine is more safe and efficacious than pregabalin. Thus this study recommends the use of desvenlafaxine for neuropathic pain over pregabalin

RM in pediatria

2003 ◽  
Vol 16 (3) ◽  
pp. 525-527
Author(s):  
M. Sabatini ◽  
E. Puglielli ◽  
F. D'Emidio ◽  
A. Splendiani ◽  
G. Arrigoni ◽  
...  
Keyword(s):  
Side Effects ◽  
Personal Experience ◽  
Diagnostic Procedures ◽  
Invasive Monitoring ◽  
Diagnostic Quality ◽  
Non Invasive ◽  
Sedation And Analgesia ◽  
Low Incidence ◽  
Effective Sedation ◽  
Vital Parameters

We describe the anaesthesiological protocol and monitoring system for children receiving sedation or general anaesthesia during MR investigation at our hospital. Constant recourse to sedation and analgesia during diagnostic procedures in children makes non-invasive monitoring of vital parameters essential in these patients. The use of short-acting drugs has the advantage of offering effective sedation with an increasingly low incidence of side effects. We report the ten year experience of a single anaesthetist monitoring children undergoing MR scans. Diagnostic quality MR investigation was possible in all cases. The personal experience of a single anaesthetist optimized an effective and safe anaesthesiological protocol.

Epidural Neostigmine Combined with Sufentanil Provides Balanced and Selective Analgesia in Early Labor

2004 ◽  
Vol 101 (2) ◽  
pp. 439-444 ◽  
Author(s):  
Fabienne Roelants ◽  
Patricia M. Lavand’homme
Keyword(s):  
Side Effects ◽  
Average Duration ◽  
Demographic Data ◽  
Test Dose ◽  
Pain Scores ◽  
Analgesic Dose ◽  
To Receive ◽  
Effective Analgesia ◽  
Vital Parameters ◽  
First Stage Of Labor

Background This study evaluated the efficacy of an epidural single dose of neostigmine combined with sufentanil to provide selective and balanced analgesia at the beginning of labor. Methods After informed consent, 125 healthy parturients were randomly allocated to receive, after a test dose, a single injection of either epidural sufentanil 20 micrograms (minimal analgesic dose) or 10 micrograms or a combination of sufentanil 10 micrograms with neostigmine 250, 500, or 750 micrograms in a total volume of 12 ml. Pain scores were recorded at regular intervals to determine onset and duration of analgesia. Maternal and fetal vital parameters as well as side effects were closely monitored. Results Parturients did not differ concerning demographic data. Epidural neostigmine 500 micrograms with sufentanil 10 micrograms produced effective analgesia (visual analog scale &lt;30 mm within 10 min in 72% parturients and within 15 min in 85% parturients; average duration of 119 min, confidence interval 96-142 min) that was as effective as epidural sufentanil 20 micrograms. Epidural combination with neostigmine 250 micrograms was ineffective, whereas 750 micrograms did not produce higher effect than 500 micrograms. No motor block was recorded. Maternal and fetal vital parameters remained stable during labor. Conclusions Epidural combination of neostigmine 500 micrograms (e.g., 6-7 micrograms/kg) with sufentanil 10 micrograms provides similar duration of analgesia as epidural sufentanil 20 micrograms and allows effective and selective analgesia devoid of side effects in the first stage of labor.

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