A Randomized Controlled Trial of Patient Controlled Analgesia Versus Continuous Infusion of Morphine during Vaso-Occlusive Crisis in Sickle Cell Disease.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3782-3782
Author(s):  
Eduard J. van Beers ◽  
Pythia T. Nieuwkerk ◽  
Charlotte F.J. van Tuijn ◽  
Philip W. Friederich ◽  
Jan H. Vranken ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Pain Score ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Group Versus ◽  
Cell Disease ◽  
Patient Controlled Analgesia ◽  
Morphine Dose ◽  
Randomized Controlled ◽  
The Mean

Abstract Pain during vaso-occlusive crisis (VOC) in sickle cell disease (SCD) is commonly treated with continuous intravenous infusion (CI) of morphine. During CI the treating physician titrates the dose of morphine until adequate relief of pain has been established. Patient controlled analgesia (PCA) allows the patient to self-administer doses of morphine for the relief of pain and has shown to be equianalgesic in post surgical patients with lower morphine consumption than with CI of morphine. Morphine has many dose-related side-effects and high plasma levels of morphine are associated with serious complications. Therefore, we conducted the first randomized controlled trial to compare the administration of morphine with PCA versus CI in sickle cell patients with VOC. 26 consecutive episodes of VOC in 21 patients with SCD were included. Patients were randomized between PCA and CI of morphine within 24 hours after hospital admission. Endpoints of the study were: the mean and cumulative morphine dose, pain intensity and quality of life (QoL). Pain intensity was measured daily using a ten-point-scale verbal pain score. Reduction of pain intensity was measured by subtracting a pain score on a ten point visual analogue scale (VAS) before randomization from the same measurement two days after randomization. QoL was measured using the Medical Outcomes Study 36-item Short Form Healthy Survey (SF36). Patients with PCA demonstrated to have significant lower morphine consumption as compared to patients randomized to CI. The mean and total cumulative morphine dose was 0.5 mg/h and 33 mg in the PCA-group versus 2.3 mg/h and 275 mg in the CI-group, respectively (p=0.02 and p<0.001). The pain intensity was not different between the groups. The mean daily ten-point-scale verbal pain score was 5.1 in the PCA group versus 5.3 in the CI-group (p=0.20). Reduction in pain intensity (VAS) two days after randomization was −2.4 in the PCA-group versus −3.8 in the CI-group (p=1.00). Also no difference in QoL was found. We conclude that the use of PCA in sickle cell patients with VOC results in adequate pain relief at a significant lower morphine dose as compared to morphine administration by continuous infusion. Figure. Mean morphine dose per patient Figure. Mean morphine dose per patient

A Randomized Controlled Trial of Patient Controlled Analgesia Versus Continuous Infusion of Morphine during Vaso-Occlusive Crisis in Sickle Cell Disease.

Blood ◽  
2006 ◽  
Vol 108 (11) ◽  
pp. 3805-3805
Author(s):  
Eduard J. Beers van ◽  
Charlotte F.J. Tuijn van ◽  
Pythia T. Nieuwkerk ◽  
Philip W. Friederich ◽  
Marcel M. Levi ◽  
...  
Keyword(s):  
Side Effects ◽  
Pain Intensity ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Morphine Consumption ◽  
Cell Disease ◽  
Patient Controlled Analgesia ◽  
Morphine Dose ◽  
Randomized Controlled ◽  
The Mean

Abstract Intravenous morphine is the treatment of choice for severe pain during vaso-occlusive crisis in sickle cell disease (SCD). However, side-effects of morphine may hamper effective treatment and high plasma levels of morphine are associated with severe complications such as acute chest syndrome. Furthermore, adequate dosing remains a problem since no objective measurement of pain severity exists and analgesia should be titrated upon the patient’s reported pain. Patient-controlled analgesia (PCA) may therefore be an interesting alternative since patients can titrate the level of analgesia themselves. Although PCA is currently used for the treatment of vaso-occlusive crises in SCD, no randomized controlled trials have been performed in admitted patients with a vaso-occlusive crisis so far. In the present study, we conducted a randomized controlled trial to compare the administration of morphine with PCA versus CI in sickle cell patients with vaso-occlusive crises. Patients were randomized between PCA and CI of morphine within 24 hours after hospital admission. Endpoints of the study were: the mean and cumulative morphine dose, pain intensity, incidence of side-effects (nausea, constipation, pruritus and drowsiness) and quality of life (QoL). Pain intensity was measured daily using a ten-point-scale verbal pain score. Reduction of pain intensity was measured by subtracting a pain score on a ten point visual analogue scale (VAS) before randomization from the same measurement two days after randomization. Side-effects were measured four times per day on a 11-point numerical rating scale. QoL was measured using the 36-item Short Form Healthy Survey (SF36). Twenty five consecutive episodes of vaso-occlusive crisis in 19 patients with SCD were included in the study. No difference in the mean daily pain scores were found between the two groups (4.9 versus 5.3). However, patients in the PCA-group demonstrated to have a strongly reduced mean and cumulative morphine consumption as compared to the patients in the CI-group (0.5 mg/h versus 2.4 mg/h (P<0.001) and 33 mg versus 260 mg (P=0.018) respectively). The lower mean and cumulative morphine consumption in the PCA-group led to significant less nausea and constipation during treatment as compared to the CI-group (area under the curve respectively 11 versus 18 (P= 0.045) and 30 versus 45 (P= 0.021)). Furthermore, a non-significant reduction in the duration of hospital admission of 3 days was observed in the PCA-group. Patient controlled analgesia results in adequate pain relief at a much lower morphine consumption and should considered to be first choice in morphine administration to sickle cell patients admitted with vaso-occlusive crisis. Figure. Mean morphine dose per patient Figure. Mean morphine dose per patient

scholarly journals Patient-controlled analgesia versus continuous infusion of morphine during vaso-occlusive crisis in sickle cell disease, a randomized controlled trial

2007 ◽  
Vol 82 (11) ◽  
pp. 955-960 ◽  
Author(s):  
Eduard J. van Beers ◽  
Charlotte F.J. van Tuijn ◽  
Pythia T. Nieuwkerk ◽  
Philip W. Friederich ◽  
Jan H. Vranken ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sickle Cell Disease ◽  
Continuous Infusion ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Cell Disease ◽  
Patient Controlled Analgesia ◽  
Randomized Controlled

scholarly journals Which Strategy to Manage Severe Vaso-occlusive Crisis in Patients with Sickle Cell Disease in Countries with Limited Healthcare Capacities?

2021 ◽  
pp. 7-13
Author(s):  
Lydie Ocini Ngolet ◽  
Chelsea Jayne Bango ◽  
Peggy Mawandza ◽  
Alexis Elira Dokekias
Keyword(s):  
Pain Relief ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Primary Objective ◽  
Cell Disease ◽  
Patient Controlled Analgesia ◽  
Secondary Objective ◽  
The Mean ◽  
The Republic

We evaluated the treatment of morphine by intravenous patient controlled analgesia versus intermittent subcutaneous routes on patients with sickle cell disease developing severe vaso-occlusivecrisis. Objectives: The primary objective was to compare intravenous patient controlled analgesia (PCA) versus intermittent subcutaneous injection of morphine (SC) on sickle cell patients developing severe vaso-occlusive crisis during the first 24 hours of admission. The secondary objective was to assess the side effects of morphine in both regimens. Methods: A randomized controlled trial of 77 patients in the PCA and 81 in the SC group was conducted at the Sickle Cell Center of Brazzaville in the Republic of Congo. Participants aged from 15 to 45 years old with severe vaso-occlusive crisis were included in the study. Results: Both regimens provided pain relief. However, a significant pain reduction was observed 30 minutes after the administration of morphine in the PCA group (P= 0.001). The mean scores in the PCA and SC regimens were respectively: 1.16±1.40 and 4.30±2.32. The total median dose of morphine administered in the PCA regimen was markedly lower: 24,6±4,16 mg versus 36.6±3.1 mg in the SC group (P=0.01). Morphine administered by PCA provided pain relief during 24 hours while intermittent severe pain was experienced in the SC group (P=0.014). Sedation score S2, S3 was significantly observed in the SC group (P< 0.05).

scholarly journals COMPARISON OF PAIN SCORE IN OSTEOARTHRITIS PATIENTS TREATED WITH A COMBINATION OF DIACEREIN AND MELOXICAM AND MELOXICAM ALONE

2017 ◽  
Vol 9 (6) ◽  
pp. 69
Author(s):  
Ni Made Oka Dwicandra ◽  
Antonious Adji Prayitno Setiadi
Keyword(s):  
Randomized Controlled Trial ◽  
Articular Cartilage ◽  
Combination Therapy ◽  
Pain Intensity ◽  
Pain Score ◽  
Controlled Trial ◽  
Area Under The Curve ◽  
Randomized Controlled ◽  
Pain Outcome ◽  
Inflammatory Drugs

Objective: Osteoarthritis (OA) is a progressive chronic disease with the loss of articular cartilage. In managing OA, inadequate pain relief (IPR) often occurs, particularly with a single non steroidal anti-inflammatory drugs (NSAIDs) therapy. In this research, pain outcome of OA patients treated with a combination of diacerein and meloxicam vs meloxicam alone was evaluated.Methods: This research was conducted at rumah sakit umum daerah (RSUD) Dr. Mohammad Soewandhie Surabaya by using randomized controlled trial (RCT) design. Pain outcome was evaluated by pain intensity and area under the curve (AUC) of pain score in week 0-4th.Results: There were a significantly different (p<0.05) in pain intensity seen in 3rd and 4th weeks after treated with a combination of diacerein and meloxicam, and with meloxicam only. However, there were no different in AUC pain score between combination and single therapy.Conclusion: Combination therapy of diacerein and meloxicam was more effective than meloxicam alone. A significant effect of a combination therapy of diacerein and meloxicam occurred at 3rd weeks. The prolong study in order to get the differences in AUC pain score are needed.

226 Ketamine Use for Acute Painful Crisis of Sickle Cell Disease: A Randomized Controlled Trial

2019 ◽  
Vol 74 (4) ◽  
pp. S89-S90 ◽  
Author(s):  
M.S. Alshahrani ◽  
A.H. Alsulaibikh ◽  
M.M. ElTahan ◽  
S.Z. AlFaraj ◽  
A.A. AlMulhim ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Cell Disease ◽  
Randomized Controlled ◽  
Painful Crisis

scholarly journals Perception of young adults with sickle cell disease or sickle cell trait about participation in the CHOICES randomized controlled trial

2015 ◽  
Vol 72 (6) ◽  
pp. 1430-1440 ◽  
Author(s):  
Patricia E. Hershberger ◽  
Agatha M. Gallo ◽  
Robert Molokie ◽  
Alexis A. Thompson ◽  
Marie L. Suarez ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Young Adults ◽  
Sickle Cell Disease ◽  
Sickle Cell ◽  
Sickle Cell Trait ◽  
Controlled Trial ◽  
Cell Disease ◽  
Randomized Controlled

A Stress and Pain Self-management m-Health App for Adult Outpatients with Sickle Cell Disease (RADIANCE Study): Protocol for a Randomized Controlled Study (Preprint)

2021 ◽  
Author(s):  
Miriam O. Ezenwa ◽  
Yingwei Yao ◽  
Molly W. Mandernach ◽  
David A. Fedele ◽  
Robert J. Lucero ◽  
...  
Keyword(s):  
Pain Intensity ◽  
Sickle Cell ◽  
Controlled Trial ◽  
Data Entry ◽  
Self Management ◽  
Opioid Use ◽  
Short Term ◽  
Self Monitoring ◽  
Randomized Controlled

BACKGROUND The purpose of this article is to describe the research protocol for a randomized controlled trial of a self-management intervention for adults diagnosed with sickle cell disease (SCD). People living with SCD suffer with lifelong recurrent episodes of acute and chronic pain, both of which are exacerbated by stress. OBJECTIVE The aims of this study are to decrease stress and improve SCD pain control with reduced opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Building on our prior findings of formative studies, this study is designed to test the efficacy of YCWS on stress intensity, pain intensity, and opioid use in adults with SCD. METHODS A randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on stress, pain, and opioid use will be conducted with 170 adults with SCD. Patients will be randomized based on a 1:1 ratio (stratified on pain intensity [<=5; >5]) to be either in the experimental (Self-monitoring of outcomes + alerts/reminders + use of YCWS [RDE + Support]) or control (Self-monitoring of outcomes + alerts/reminders) group. Patients will be asked to report outcomes daily. During weeks 1-8, patients in both groups will receive system-generated alerts/reminders via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the participant does not enter data after 24 hours, the study support staff will contact him/her for data entry troubleshooting (both groups) and YCWS use (experimental). We will time stamp and track patients' online activities to understand the study context and conduct exit interviews on the acceptability of system-generated and staff support. RESULTS The study was funded by the National Institute of Nursing Research of the National Institutes of Health in 2020. Our Institutional Review Board approved this study. Currently in the recruitment phase, the study began in March 2021 and will be concluded in June 2025. As of September 2021, we have enrolled 40 patients. We will analyze the data using the mixed-effects regression models (short-term, long-term) to account for the repeated measurements over time and utilize machine-learning to construct and evaluate prediction models. Due to the COVID-19 pandemic, the study was modified to allow for a mail-in consent process and a virtual consent process via email or Zoom video conference. CONCLUSIONS We expect that the intervention group will report reductions in pain intensity (primary outcome, 0-10 scale) and in stress intensity (0-10 scale) and opioid use, which are secondary outcomes. Our study will contribute to advancing the use of non-opioid therapy such as guided relaxation/distraction techniques for managing sickle cell pain. CLINICALTRIAL ClinicalTrials.gov NCT04484272

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