Arnold-Chiari MalformationPhase 2NCT02532322
Efficacy of Acetaminophen in Posterior Fossa Surgery
A Phase 2 study testing IV acetaminophen and normal saline in people with Arnold-Chiari Malformation and Posterior Fossa Tumors, run by Children's National Research Institute at 1 site in United States.
Trial summary
Uncontrolled pain after posterior fossa surgery and associated negative side effects of conventional opioid therapy causes significant morbidity and mortality in infants and children. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Arnold-Chiari Malformation, Posterior Fossa Tumors
- What is being tested?
- IV acetaminophen and normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2015to Oct 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Any child undergoing posterior fossa surgery, including surgery for Chiari Malformation
- The subject's American Society of Anesthesiologists physical status is 1, 2 or 3
- Males and females 2 to 12 years old (minorities will be included) - recommended dosing of IV acetaminophen in children is approved for children 2 to 12 years of age
- Written informed consent from parent/guardian
Who cannot join
- Subjects with known or suspected hypersensitivity reaction to acetaminophen
- Presence or prior history of a known liver disease or coagulation disorder:
- History of abnormal liver function
- History of prior liver transplantation
- Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)
- History of prior acetaminophen overdose
Show all 13Show fewer
- Subjects with the need for mechanical ventilation prior to surgery or postoperatively - unable to assess accurate pain scores in this context
- The subject has a history or a family (parent or sibling) history of malignant hyperthermia
- The subject had a recent opioid exposure (within 1 month of surgery)
- The subject is obese (body mass index >30 kg/m2)
- The subject is an American Society of Anesthesiologist physical status classification of 4 or greater
- The subject is scheduled for a surgical sub-procedure
- Subjects who have been previously enrolled in this protocol may not be enrolled again
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Official title: Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery
Uncontrolled pain after posterior fossa surgery and associated negative side effects of conventional opioid therapy causes significant morbidity and mortality in infants and children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children. However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in children undergoing posterior fossa surgery. In this prospective, randomized controlled trial, the investigators aim to determine whether the addition of IV acetaminophen for 24 hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical procedures of the posterior fossa compared with conventional therapy.
Read the detailed description
The primary goal of this study is to compare the efficacy of IV acetaminophen to placebo in pediatric patients undergoing posterior fossa surgery, with the primary outcome measure being postoperative opioid requirements (morphine equivalent mg/kg). This will be a prospective, randomized, double blind control trial. The patient, research team, surgeon, and anesthesiologist will all be blinded to the patient's treatment group. Patients will receive either IV acetaminophen or equal volume normal saline (placebo) in the perioperative period.
The interventional component of this study involves the intraoperative and postoperative administration of IV acetaminophen. Intraoperative and postoperative data pertaining to adverse events would be collected for safety monitoring purposes.
Enrolled subjects will be randomized to receive either IV acetaminophen or equal volume saline placebo during surgery and for 24 hours postoperatively. According to a computer-generated table of random number assignments, each patient will be randomly assigned to receive one of the following two treatment groups:
Treatment group 1:
IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively). This dosing regimen was chosen based on pharmacokinetic data and recommended dosing guidelines for IV acetaminophen in children 2 to 12 years of age.
Treatment group 2:
Equal volume of normal saline (placebo control) at the same dose and frequency as treatment group 1.
Loading dose volumes and subsequent doses every 6 hours will be determined based on weight of the patient such that they will receive equal volumes of either IV acetaminophen or saline.
Maintenance of anesthesia, including opioid administration, and perioperative management will proceed as per routine care.
POSTOPERATIVE ANALGESIA
At the completion of surgery, the anesthetic agents will be discontinued as per routine care. Per routine care, after tracheal extubation, morphine (0.05 mg/kg/dose) will be administered as needed by the blinded assessor until the patient appears comfortable, defined as the absence of any verbal or behavioral expression of pain. Patients will then be transferred to the intensive care unit (ICU).
Time of entry into the intensive care unit will be recorded. The following assessments will be recorded at time of admission to the ICU:
- vital signs (heart rate, respiratory rate, blood pressure)
- oxygen saturation
- pain score
- sedation score
As part of routine care for postoperative analgesia, patients will receive morphine sulfate at standard doses (0.05 - 0.1 mg/kg/dose every 3 hours as needed for pain). The frequency and dose of morphine will be adjusted according to the patient's pain score, with a goal to maintain a pain score of < 6. In addition, patients will transition to oral opioids as soon as their diet allows.
The following parameters will be used to measure short-term postoperative analgesia and side effects:
- Daily opioid consumption (mg/kg/24h in morphine equivalent using the conversion)
- Pain scores at rest
- Sedation score
- The incidence of post-operative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics: i.e. ondansetron or promethazine given as needed.
- The incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic: i.e. diphenhydramine or hydroxyzine given as needed for pruritus
- The incidence of pyrexia (defined as core temperature ≥ 38º Celsius). Ketorolac will be administered 0.5 mg/kg q6h prn as needed for pyrexia as per routine care.
Data collection will continue for up to 72 hours postoperatively.
DATA ANALYSIS
Data will be analyzed to determine the decrease in postoperative opioid requirements with or without IV acetaminophen after posterior fossa surgery as the primary outcome. The investigators hypothesize that IV acetaminophen will decrease postoperative opioid requirements, pain and sedation scores, and opioid-induced side effects in children undergoing posterior fossa surgery.
- Conditions
- Arnold-Chiari Malformation, Posterior Fossa Tumors
- Being tested
- IV acetaminophen, normal saline
- Medical subject headings
- Arnold-Chiari Malformation, Infratentorial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV acetaminophenDrug
Also called Tylenol, APAP
IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
normal salineDrug
Also called saline placebo, NS 0.9%
normal saline 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
| Study group | Role | What they receive |
|---|---|---|
| IV acetaminophen | Experimental | IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively) Receives: Drug: IV acetaminophen |
| normal saline | Placebo comparator | normal saline (placebo control) 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively) Receives: Drug: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily opioid consumption (mg/kg/24 hours using morphine equivalent)
Equianalgesic conversion of opioid consumption to morphine equivalent will be used
Measured: 72 hours postoperatively
Secondary outcomes (3)
Average daily pain scores using Wong-Baker Faces or Numeric Pain Scale
Scores range from 0 [no pain] to 10 [worst possible pain]
Measured: 72 hours postoperatively
Average daily sedation scores using University of Michigan Sedation Scale
Score range from 0 [completely awake] to 4 [asleep but not responsive to any stimuli]
Measured: 72 hours postoperatively
Incidence of opioid-induced side effects
- Incidence of postoperative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics (i.e. ondansetron or promethazine given as needed)
- Incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic (i.e. diphenhydramine or hydroxyzine given as needed for pruritus)
Measured: 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2018 (estimated)
- Study completionOct 2018 (estimated)
Why it stopped: not enough patients meeting criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Arnold-Chiari MalformationStudies of the same condition, open and under way.
- More trials run by Children's National Research InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Srijaya K. Reddy, MD, MBA, Children's National Research Institute
- Investigators
- Srijaya K Reddy, MD, MBA, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532322
- Sponsor's protocol ID
- PRO00006330
- Status last verified
- Apr 2021
- First submitted
- 21 Aug 2015
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
De Benedittis G, Lorenzetti A, Migliore M, Spagnoli D, Tiberio F, Villani RM. Postoperative pain in neurosurgery: a pilot study in brain surgery. Neurosurgery. 1996 Mar;38(3):466-9; discussion 469-70. doi: 10.1097/00006123-199603000-00008.
PubMed 8837797Morad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9.
PubMed 22156333Baley K, Michalov K, Kossick MA, McDowell M. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. AANA J. 2014 Feb;82(1):53-64.
PubMed 24654353Alhashemi JA, Daghistani MF. Effect of intraoperative intravenous acetaminophen vs. intramuscular meperidine on pain and discharge time after paediatric dental restoration. Eur J Anaesthesiol. 2007 Feb;24(2):128-33. doi: 10.1017/S0265021506001232. Epub 2006 Aug 8.
PubMed 16895621Alhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. doi: 10.1093/bja/ael084. Epub 2006 Apr 13.
PubMed 16613928Lahtinen P, Kokki H, Hendolin H, Hakala T, Hynynen M. Propacetamol as adjunctive treatment for postoperative pain after cardiac surgery. Anesth Analg. 2002 Oct;95(4):813-9, table of contents. doi: 10.1097/00000539-200210000-00005.
PubMed 12351250
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Intravenous Acetaminophen as Analgesic Adjuvant Therapy in Children Undergoing Posterior Fossa Surgery
- ClinicalTrials.gov ID
- NCT02532322
- Acronym / sponsor ID
- PRO00006330
- Conditions
- Arnold-Chiari Malformation, Posterior Fossa Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not enough patients meeting criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 25 Aug 2015 (estimated)
- 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.
Uncontrolled pain after posterior fossa surgery and associated negative side effects of conventional opioid therapy causes significant morbidity and mortality in infants and children. Intravenous (IV) acetaminophen has been shown to be effective in treating mild to moderate pain, and moderate to severe pain in conjunction with adjuvant opioids in children. However, it is unknown if IV acetaminophen is effective as analgesic adjuvant therapy in children undergoing posterior fossa surgery. In this prospective, randomized controlled trial, the investigators aim to determine whether the addition of IV acetaminophen for 24 hours can lead to reduction in postoperative pain and opioid requirement after neurosurgical procedures of the posterior fossa compared with conventional therapy.
Detailed description
The primary goal of this study is to compare the efficacy of IV acetaminophen to placebo in pediatric patients undergoing posterior fossa surgery, with the primary outcome measure being postoperative opioid requirements (morphine equivalent mg/kg). This will be a prospective, randomized, double blind control trial. The patient, research team, surgeon, and anesthesiologist will all be blinded to the patient's treatment group. Patients will receive either IV acetaminophen or equal volume normal saline (placebo) in the perioperative period.
The interventional component of this study involves the intraoperative and postoperative administration of IV acetaminophen. Intraoperative and postoperative data pertaining to adverse events would be collected for safety monitoring purposes.
Enrolled subjects will be randomized to receive either IV acetaminophen or equal volume saline placebo during surgery and for 24 hours postoperatively. According to a computer-generated table of random number assignments, each patient will be randomly assigned to receive one of the following two treatment groups:
Treatment group 1:
IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively). This dosing regimen was chosen based on pharmacokinetic data and recommended dosing guidelines for IV acetaminophen in children 2 to 12 years of age.
Treatment group 2:
Equal volume of normal saline (placebo control) at the same dose and frequency as treatment group 1.
Loading dose volumes and subsequent doses every 6 hours will be determined based on weight of the patient such that they will receive equal volumes of either IV acetaminophen or saline.
Maintenance of anesthesia, including opioid administration, and perioperative management will proceed as per routine care.
POSTOPERATIVE ANALGESIA
At the completion of surgery, the anesthetic agents will be discontinued as per routine care. Per routine care, after tracheal extubation, morphine (0.05 mg/kg/dose) will be administered as needed by the blinded assessor until the patient appears comfortable, defined as the absence of any verbal or behavioral expression of pain. Patients will then be transferred to the intensive care unit (ICU).
Time of entry into the intensive care unit will be recorded. The following assessments will be recorded at time of admission to the ICU:
- vital signs (heart rate, respiratory rate, blood pressure)
- oxygen saturation
- pain score
- sedation score
As part of routine care for postoperative analgesia, patients will receive morphine sulfate at standard doses (0.05 - 0.1 mg/kg/dose every 3 hours as needed for pain). The frequency and dose of morphine will be adjusted according to the patient's pain score, with a goal to maintain a pain score of < 6. In addition, patients will transition to oral opioids as soon as their diet allows.
The following parameters will be used to measure short-term postoperative analgesia and side effects:
- Daily opioid consumption (mg/kg/24h in morphine equivalent using the conversion)
- Pain scores at rest
- Sedation score
- The incidence of post-operative nausea and vomiting (PONV) will be assessed by the need for rescue antiemetics: i.e. ondansetron or promethazine given as needed.
- The incidence and severity of pruritus will be assessed by the need for rescue anti-pruritic: i.e. diphenhydramine or hydroxyzine given as needed for pruritus
- The incidence of pyrexia (defined as core temperature ≥ 38º Celsius). Ketorolac will be administered 0.5 mg/kg q6h prn as needed for pyrexia as per routine care.
Data collection will continue for up to 72 hours postoperatively.
DATA ANALYSIS
Data will be analyzed to determine the decrease in postoperative opioid requirements with or without IV acetaminophen after posterior fossa surgery as the primary outcome. The investigators hypothesize that IV acetaminophen will decrease postoperative opioid requirements, pain and sedation scores, and opioid-induced side effects in children undergoing posterior fossa surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IV acetaminophen | Experimental | Drug: IV acetaminophenIV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively) |
| normal saline | Placebo comparator | Drug: normal salinenormal saline (placebo control) 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively) |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Any child undergoing posterior fossa surgery, including surgery for Chiari Malformation
- The subject's American Society of Anesthesiologists physical status is 1, 2 or 3
- Males and females 2 to 12 years old (minorities will be included) - recommended dosing of IV acetaminophen in children is approved for children 2 to 12 years of age
- Written informed consent from parent/guardian
Key exclusion criteria (13 listed)
- Subjects with known or suspected hypersensitivity reaction to acetaminophen
- Presence or prior history of a known liver disease or coagulation disorder:
- History of abnormal liver function
- History of prior liver transplantation
- Subjects who are on anticoagulant therapy (Coumadin, heparin, aspirin, etc.)
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 |
|---|---|---|
| IV acetaminophenAlso: Tylenol, APAPIV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively) | Drug | IV acetaminophen |
| normal salineAlso: saline placebo, NS 0.9%normal saline 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively) | Drug | normal saline |
Primary outcome
Daily opioid consumption (mg/kg/24 hours using morphine equivalent)
Time frame: 72 hours postoperatively
Equianalgesic conversion of opioid consumption to morphine equivalent will be used
3 secondary outcomes
Average daily pain scores using Wong-Baker Faces or Numeric Pain Scale
Time frame: 72 hours postoperatively
Average daily sedation scores using University of Michigan Sedation Scale
Time frame: 72 hours postoperatively
Incidence of opioid-induced side effects
Time frame: 72 hours postoperatively
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Background: PubMed 8837797De Benedittis G, Lorenzetti A, Migliore M, Spagnoli D, Tiberio F, Villani RM. Postoperative pain in neurosurgery: a pilot study in brain surgery. Neurosurgery. 1996 Mar;38(3):466-9; discussion 469-70. doi: 10.1097/00006123-199603000-00008.
- Background: PubMed 22156333Morad A, Winters B, Stevens R, White E, Weingart J, Yaster M, Gottschalk A. The efficacy of intravenous patient-controlled analgesia after intracranial surgery of the posterior fossa: a prospective, randomized controlled trial. Anesth Analg. 2012 Feb;114(2):416-23. doi: 10.1213/ANE.0b013e31823f0c5a. Epub 2011 Dec 9.
- Background: PubMed 24654353Baley K, Michalov K, Kossick MA, McDowell M. Intravenous acetaminophen and intravenous ketorolac for management of pediatric surgical pain: a literature review. AANA J. 2014 Feb;82(1):53-64.
- Background: PubMed 16895621Alhashemi JA, Daghistani MF. Effect of intraoperative intravenous acetaminophen vs. intramuscular meperidine on pain and discharge time after paediatric dental restoration. Eur J Anaesthesiol. 2007 Feb;24(2):128-33. doi: 10.1017/S0265021506001232. Epub 2006 Aug 8.
- Background: PubMed 16613928Alhashemi JA, Daghistani MF. Effects of intraoperative i.v. acetaminophen vs i.m. meperidine on post-tonsillectomy pain in children. Br J Anaesth. 2006 Jun;96(6):790-5. doi: 10.1093/bja/ael084. Epub 2006 Apr 13.
- Background: PubMed 12351250Lahtinen P, Kokki H, Hendolin H, Hakala T, Hynynen M. Propacetamol as adjunctive treatment for postoperative pain after cardiac surgery. Anesth Analg. 2002 Oct;95(4):813-9, table of contents. doi: 10.1097/00000539-200210000-00005.
- 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. This study is not recruiting at the moment.
Srijaya K Reddy, MD, MBA principal investigator
Children's National Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IV acetaminophen and normal saline in people with Arnold-Chiari Malformation and Posterior Fossa Tumors, run by Children's National Research Institute at 1 site in United States.
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 4 inclusion and 13 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: withdrawn, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily opioid consumption (mg/kg/24 hours using morphine equivalent) (time frame: 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02532322, which also lists 6 linked publications.
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 8 Apr 2021.