Sickle Cell DiseasePhase 4PAMAVOCNCT07826988
Adaptive Platform Trial for Pain Management in Sickle Cell Vaso-Occlusive Crisis
A Phase 4 study testing Group 02 Paracetamol + Morphine + Ketamine, Group 03 : Paracetamol + Morphine + Nefopam and Group 04 : Paracetamol + Morphine + Nefopam + Ketamine in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Sickle cell disease (SCD) is a severe hemoglobinopathy, characterized by recurrent vaso-occlusive crises (VOC) causing intense pain and frequent hospitalizations in adult patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease, Vaso-occlusive Crisis
- What is being tested?
- Group 02 Paracetamol + Morphine + Ketamine, Group 03 : Paracetamol + Morphine + Nefopam and Group 04 : Paracetamol + Morphine + Nefopam + Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 1 Jan 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥18 years)
- Diagnosed with major sickle cell syndrome (SS homozygous, SC or Sβ° or Sβ+ thalassemia compound heterozygous)
- Hospitalized and presenting with a vaso-occlusive crisis (VOC), defined as acute pain or tenderness affecting at least one part of the body, including the limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other causes
- Requiring intravenous morphine or its derivatives
- Informed consent obtained from the patient (or from a trusted support person, family member, or relative), or emergency inclusion procedure in cases where the patient is unable to consent and no trusted support person, family member, or relative is available
Who cannot join
- Refusal to participate
- Pregnant or breastfeeding patient
- Administration of one of the interventional group treatments within 4 hours prior to inclusion
- Intravenous morphine treatment for more than 24 hours
- Patient already included in the study within the previous 3 months
- Patient receiving long-term opioid therapy
Show all 20Show fewer
- Not affiliated with a social security scheme, or patient under State Medical Aid (AME)
- Patient under legal protection measures (guardianship / family authorization with representation mandate / future protection mandate) or under supervised guardianship (curatelle)
- Patient deprived of liberty
- Participation in another clinical trial involving a drug
- Participation in the PAMAVOC trial within the previous 3 months
- Contraindication to standard VOC treatment:
- Hypersensitivity to opioids
- Opioid-induced hyperalgesia, defined by increased pain on nociceptive testing, topographic extension, or the onset of allodynia with increasing opioid doses
- Renal impairment, defined as creatinine clearance ≤30 mL/minute
- Hepatocellular impairment, defined as prothrombin time <40%
- Impaired consciousness, defined as a Glasgow Coma Scale score ≤13/15
- Exclusion from a Specific Intervention (randomization possible to other study arms):
- Hypersensitivity to the active substance or to any of the excipients
- Respective contraindications to nefopam, tramadol, ketoprofen, and ketamine, as described in their respective Summaries of Product Characteristics (SmPC)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Adaptive Platform Trial for Pain Management During Vaso-Occlusive Crisis in Adult Patients With Sickle Cell Disease
Sickle cell disease (SCD) is a severe hemoglobinopathy, characterized by recurrent vaso-occlusive crises (VOC) causing intense pain and frequent hospitalizations in adult patients. Current French and British guidelines recommend rapid administration of strong opioids, primarily through patient-controlled analgesia (PCA), as the reference treatment for hospitalized patients experiencing VOC. However, opioid use is associated with dose-dependent adverse effects, including nausea, constipation, pruritus, sedation, and hypoventilation, the latter representing a risk factor for acute chest syndrome.
The hypothesis underlying this study is that multimodal analgesia-combining morphine PCA with co-analgesics such as paracetamol-can significantly reduce morphine consumption during hospitalization compared to opioid-only analgesia, while maintaining effective pain control. Although several co-analgesic agents (paracetamol, NSAIDs, nefopam, tramadol, ketamine) are recommended by expert guidelines, including those from the American Society of Hematology (2020) and French recommendations (2025), the level of evidence supporting their use in adult sickle cell patients remains low or non-existent for most agents, with no randomized controlled trials available for nefopam, tramadol, or ketamine.
Using an adaptive platform design, this trial aims to compare multiple analgesic strategies against standard opioid-based care, generating higher-quality evidence to optimize pain management protocols for adult patients experiencing VOC
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Being tested
- Group 02 Paracetamol + Morphine + Ketamine, Group 01 Control: Paracetamol + Morphine, Group 03 : Paracetamol + Morphine + Nefopam, Group 04 : Paracetamol + Morphine + Nefopam + Ketamine, Goup 05 : Paracetamol + Morphine + Tramadol
- Keywords
- Sickle cell disease, Multimodal Analgesia, Patient-Controlled Analgesia, Pain Management, Vaso-Occlusive Crisis
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 02 Paracetamol + Morphine + KetamineDrug
Participants receive intravenous paracetamol and morphine via PCA. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment.
Group 01 Control: Paracetamol + MorphineDrug
Participants receive intravenous paracetamol and morphine via patient-controlled analgesia (PCA). In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment
Group 03 : Paracetamol + Morphine + NefopamDrug
Participants receive intravenous paracetamol, morphine via PCA, and nefopam. In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment.
Group 04 : Paracetamol + Morphine + Nefopam + KetamineDrug
Participants receive intravenous paracetamol, morphine via PCA, and nefopam. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment.
Goup 05 : Paracetamol + Morphine + TramadolDrug
Participants receive intravenous paracetamol, morphine via PCA, and tramadol. In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment.
Group 6 : Paracetamol + Morphine + Tramadol + KetamineDrug
Participants receive intravenous paracetamol, morphine via PCA, and tramadol. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment.
Group 7 : Paracetamol + Morphine + KetoprofenDrug
Participants receive intravenous paracetamol, morphine via PCA, and ketoprofen. In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment.
Group 08 : Paracetamol + Morphine + Ketoprofen + KetamineDrug
Participants receive intravenous paracetamol, morphine via PCA, and ketoprofen. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment.
| Study group | Role | What they receive |
|---|---|---|
| Group 01 Control : Paracetamol + Morphine | Active comparator | Not described Receives: Drug: Group 01 Control: Paracetamol + Morphine |
| group 02 : Paracetamol + Morphine + Ketamine | Experimental | Not described Receives: Drug: Group 02 Paracetamol + Morphine + Ketamine |
| Group 03 : Paracetamol + Morphine + Nefopam | Experimental | Not described Receives: Drug: Group 03 : Paracetamol + Morphine + Nefopam |
| Group 04 : Paracetamol + Morphine + Nefopam + Ketamine | Experimental | Not described Receives: Drug: Group 04 : Paracetamol + Morphine + Nefopam + Ketamine |
| Group 05 : Paracetamol + Morphine + Tramadol | Experimental | Not described Receives: Drug: Goup 05 : Paracetamol + Morphine + Tramadol |
| Group 06 : Paracetamol + Morphine + Tramadol + Ketamine | Experimental | Not described Receives: Drug: Group 6 : Paracetamol + Morphine + Tramadol + Ketamine |
| Group 07 : Paracetamol + Morphine + Ketoprofen | Experimental | Not described Receives: Drug: Group 7 : Paracetamol + Morphine + Ketoprofen |
| Group 08 : Paracetamol + Morphine + Ketoprofen + Ketamine | Experimental | Not described Receives: Drug: Group 08 : Paracetamol + Morphine + Ketoprofen + Ketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of vaso-occlusive crisis (VOC)
Time to resolution of vaso-occlusive crisis is defined as the time from randomization to discontinuation of intravenous opioid therapy, measured in hours.
Measured: Up to 14 days after randomization.
Secondary outcomes (10)
Intravenous Morphine Consumption
Cumulative dose (mg) and mean daily dose (mg/day) of intravenous morphine.
Measured: From admission to discharge, assessed up to 14 dayss)
Transfusion Requirements
Number of red blood cell units transfused.
Measured: From admission to discharge, assessed up to 14 days
Intensive Care Unit Admission
Admission to intensive care unit during hospitalization.
Measured: From admission to discharge, assessed up to 14 days
Morphine-Related Adverse Effects
Constipation, sedation (impaired consciousness requiring opioid discontinuation or naloxone administration), vomiting, and secondary acute chest syndrome (new pulmonary infiltrate associated with a clinical sign such as fever, or a respiratory sign such as chest pain or dyspnea).
Measured: Within 3 months (+/- 15 days)
Length of Hospital Stay
Duration of hospitalization, measured in days
Measured: From admission to discharge, assessed up to 14 days
Hyperalgic Vaso-Occlusive Crisis
Uncontrolled pain requiring morphine titration >1 mg/kg or total intravenous morphine consumption >2 mg/kg/24h.
Measured: from randomization to discontinuation of intravenous opioid therapy Up to 14 days
Refractory Vaso-Occlusive Crisis
Visual analog scale (VAS) score >7/10 after administration of study treatments and a new morphine titration (1 mg/kg).
Measured: From randomization to discontinuation of intravenous opioid therapy Up to 14 days
Adverse Effects of Investigational Medicinal Products
Including nefopam (seizure); NSAIDs (acute kidney injury, KDIGO stage >0; gastrointestinal or other bleeding); tramadol (seizure, liver function abnormalities, impaired consciousness with GCS <14/15); ketamine (liver function abnormalities, hallucinations, impaired consciousness with GCS <14/15, venous access complications).
Measured: Within 3 months (+/- 15 days)
In-Hospital Mortality
Death occurring during hospitalization.
Measured: Duration of hospital stay, assessed up to 14 days
Unplanned Readmission
Unplanned hospital readmission within 3 months following the index hospitalization.
Measured: Within 3 months (+/- 15 days) after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion14 Oct 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ségolène GENDREAU, MD, PhD, Study chair, Assistance public Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07826988
- Sponsor's protocol ID
- APHP251244
- Other IDs
- 2026-527112-16-00
- Acronym
- PAMAVOC
- Status last verified
- Jul 2026
- First submitted
- 28 Jul 2026
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Platform Trial for Pain Management During Vaso-Occlusive Crisis in Adult Patients With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT07826988
- Acronym / sponsor ID
- PAMAVOC / APHP251244
- Conditions
- Sickle Cell Disease, Vaso-occlusive Crisis
- Keywords
- Sickle cell disease, Multimodal Analgesia, Patient-Controlled Analgesia, Pain Management, Vaso-Occlusive Crisis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 14 Oct 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 18 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sickle cell disease (SCD) is a severe hemoglobinopathy, characterized by recurrent vaso-occlusive crises (VOC) causing intense pain and frequent hospitalizations in adult patients. Current French and British guidelines recommend rapid administration of strong opioids, primarily through patient-controlled analgesia (PCA), as the reference treatment for hospitalized patients experiencing VOC. However, opioid use is associated with dose-dependent adverse effects, including nausea, constipation, pruritus, sedation, and hypoventilation, the latter representing a risk factor for acute chest syndrome.
The hypothesis underlying this study is that multimodal analgesia-combining morphine PCA with co-analgesics such as paracetamol-can significantly reduce morphine consumption during hospitalization compared to opioid-only analgesia, while maintaining effective pain control. Although several co-analgesic agents (paracetamol, NSAIDs, nefopam, tramadol, ketamine) are recommended by expert guidelines, including those from the American Society of Hematology (2020) and French recommendations (2025), the level of evidence supporting their use in adult sickle cell patients remains low or non-existent for most agents, with no randomized controlled trials available for nefopam, tramadol, or ketamine.
Using an adaptive platform design, this trial aims to compare multiple analgesic strategies against standard opioid-based care, generating higher-quality evidence to optimize pain management protocols for adult patients experiencing VOC
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group 01 Control : Paracetamol + Morphine | Active comparator | Drug: Group 01 Control: Paracetamol + Morphine |
| group 02 : Paracetamol + Morphine + Ketamine | Experimental | Drug: Group 02 Paracetamol + Morphine + Ketamine |
| Group 03 : Paracetamol + Morphine + Nefopam | Experimental | Drug: Group 03 : Paracetamol + Morphine + Nefopam |
| Group 04 : Paracetamol + Morphine + Nefopam + Ketamine | Experimental | Drug: Group 04 : Paracetamol + Morphine + Nefopam + Ketamine |
| Group 05 : Paracetamol + Morphine + Tramadol | Experimental | Drug: Goup 05 : Paracetamol + Morphine + Tramadol |
| Group 06 : Paracetamol + Morphine + Tramadol + Ketamine | Experimental | Drug: Group 6 : Paracetamol + Morphine + Tramadol + Ketamine |
| Group 07 : Paracetamol + Morphine + Ketoprofen | Experimental | Drug: Group 7 : Paracetamol + Morphine + Ketoprofen |
| Group 08 : Paracetamol + Morphine + Ketoprofen + Ketamine | Experimental | Drug: Group 08 : Paracetamol + Morphine + Ketoprofen + Ketamine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients (age ≥18 years)
- Diagnosed with major sickle cell syndrome (SS homozygous, SC or Sβ° or Sβ+ thalassemia compound heterozygous)
- Hospitalized and presenting with a vaso-occlusive crisis (VOC), defined as acute pain or tenderness affecting at least one part of the body, including the limbs, ribs, sternum, head (skull), spine, and/or pelvis, not attributable to other causes
- Requiring intravenous morphine or its derivatives
- Informed consent obtained from the patient (or from a trusted support person, family member, or relative), or emergency inclusion procedure in cases where the patient is unable to consent and no trusted support person, family member, or relative is available
Key exclusion criteria (20 listed)
- Refusal to participate
- Pregnant or breastfeeding patient
- Administration of one of the interventional group treatments within 4 hours prior to inclusion
- Intravenous morphine treatment for more than 24 hours
- Patient already included in the study within the previous 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group 02 Paracetamol + Morphine + KetamineParticipants receive intravenous paracetamol and morphine via PCA. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment. | Drug | group 02 : Paracetamol + Morphine + Ketamine |
| Group 01 Control: Paracetamol + MorphineParticipants receive intravenous paracetamol and morphine via patient-controlled analgesia (PCA). In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment | Drug | Group 01 Control : Paracetamol + Morphine |
| Group 03 : Paracetamol + Morphine + NefopamParticipants receive intravenous paracetamol, morphine via PCA, and nefopam. In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment. | Drug | Group 03 : Paracetamol + Morphine + Nefopam |
| Group 04 : Paracetamol + Morphine + Nefopam + KetamineParticipants receive intravenous paracetamol, morphine via PCA, and nefopam. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment. | Drug | Group 04 : Paracetamol + Morphine + Nefopam + Ketamine |
| Goup 05 : Paracetamol + Morphine + TramadolParticipants receive intravenous paracetamol, morphine via PCA, and tramadol. In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment. | Drug | Group 05 : Paracetamol + Morphine + Tramadol |
| Group 6 : Paracetamol + Morphine + Tramadol + KetamineParticipants receive intravenous paracetamol, morphine via PCA, and tramadol. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment. | Drug | Group 06 : Paracetamol + Morphine + Tramadol + Ketamine |
| Group 7 : Paracetamol + Morphine + KetoprofenParticipants receive intravenous paracetamol, morphine via PCA, and ketoprofen. In case of hyperalgic VOC, morphine dosage may be increased according to the treating physician's judgment. | Drug | Group 07 : Paracetamol + Morphine + Ketoprofen |
| Group 08 : Paracetamol + Morphine + Ketoprofen + KetamineParticipants receive intravenous paracetamol, morphine via PCA, and ketoprofen. In case of hyperalgic VOC, low-dose ketamine may be added as a co-analgesic, off-label, according to the treating physician's judgment. | Drug | Group 08 : Paracetamol + Morphine + Ketoprofen + Ketamine |
Primary outcome
Time to resolution of vaso-occlusive crisis (VOC)
Time frame: Up to 14 days after randomization.
Time to resolution of vaso-occlusive crisis is defined as the time from randomization to discontinuation of intravenous opioid therapy, measured in hours.
10 secondary outcomes
Intravenous Morphine Consumption
Time frame: From admission to discharge, assessed up to 14 dayss)
Transfusion Requirements
Time frame: From admission to discharge, assessed up to 14 days
Intensive Care Unit Admission
Time frame: From admission to discharge, assessed up to 14 days
Morphine-Related Adverse Effects
Time frame: Within 3 months (+/- 15 days)
Length of Hospital Stay
Time frame: From admission to discharge, assessed up to 14 days
Hyperalgic Vaso-Occlusive Crisis
Time frame: from randomization to discontinuation of intravenous opioid therapy Up to 14 days
Refractory Vaso-Occlusive Crisis
Time frame: From randomization to discontinuation of intravenous opioid therapy Up to 14 days
Adverse Effects of Investigational Medicinal Products
Time frame: Within 3 months (+/- 15 days)
In-Hospital Mortality
Time frame: Duration of hospital stay, assessed up to 14 days
Unplanned Readmission
Time frame: Within 3 months (+/- 15 days) after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ségolène GENDREAU, MD, PhD study chair
Assistance public Hôpitaux de Paris
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group 02 Paracetamol + Morphine + Ketamine, Group 03 : Paracetamol + Morphine + Nefopam and Group 04 : Paracetamol + Morphine + Nefopam + Ketamine in people with Sickle Cell Disease and Vaso-occlusive Crisis, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Samia BALOUL (01 49 81 33 85, samia.baloul@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to resolution of vaso-occlusive crisis (VOC) (time frame: Up to 14 days after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.