Pain, PostoperativePhase 4IVA POP NICUNCT05678244
Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit
A Phase 4 study testing Acetaminophen in people with Pain, Postoperative and Pain, run by McMaster Children's Hospital at 1 site in Canada.
Trial summary
The goal of this pilot randomized clinical trial is to determine the effect of the addition of IV acetaminophen to opioid-based pain regimes for infants admitted to the neonatal intensive care unit (NICU) after surgery. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Pain, Postoperative, Pain
- What is being tested?
- Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 17 Apr 2023to Sep 2024
- Phase
- Phase 4
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates, admitted to McMaster Children's Hospital NICU
- Has had major open, thoracic or abdominal surgery (see appendix 1, table 6).
- Informed consent obtained from guardian(s)
Who cannot join
- Hepatic dysfunction
- AST, ALT or Bilirubin > 3x upper limit of normal
- INR ≥ 3.0 or PT greater than 20s regardless of vitamin K administration
- Renal dysfunction
- Increase in serum creatinine ≥ 2x baseline (baseline: lowest value in first 5 days of hospitalization)
- Urine output < 0.5 mL/kg/h for ≥ 12h
Show all 15Show fewer
- Allergy or intolerance to acetaminophen or fentanyl
- Acetaminophen administration within 24 hours of the end of surgery
- Nerve blocks or epidurals
- Refusal or withdrawal of consent
- Enrolment in another competing trial
- No later than 12 hours after the end of surgery
- 12 months post gestational age or greater in age
- Birthweight greater or equal to 2,500g.
- Discharged from the McMaster NICU
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5
Victoria Archer, MD, 5067219285, vicki.archer@medportal.ca
About this study
Official title: Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit: A Feasibility Randomized Controlled Trial
The goal of this pilot randomized clinical trial is to determine the effect of the addition of IV acetaminophen to opioid-based pain regimes for infants admitted to the neonatal intensive care unit (NICU) after surgery.
This is a pilot trial; the main goals are to make sure our study methods work before performing a larger study.
Read more
The main clinical aims are:
- Determine if adding IV acetaminophen reduces pain
- Determine if adding IV acetaminophen reduces opioid use
- Determine if adding IV acetaminophen reduces complications
Participants will be randomized to two groups:
Comparator: Fentanyl and IV acetaminophen Control: Fentanyl and placebo
Patients will receive either IV acetaminophen or placebo at regular intervals for seven days after surgery. Patients will be followed daily during that period. Charts will be reviewed at 90-days for final outcomes.
Read the detailed description
Purpose: Opioid use in neonates is associated with short and long-term adverse events. Multi-modal pain control offers the ability to control pain while reducing opioid exposure. This topic has been relatively unexamined in preterm and term neonates. Specifically, this trial aims to evaluate the effect of adding IV acetaminophen to standard opioid-based pain regimes in neonates in the neonatal intensive care unit (NICU) undergoing major abdominal and thoracic surgery.
Objectives: The primary aim of the proposed study is to determine the feasibility and cost of conducting a multicenter, randomized control trial to compare the efficacy of IV acetaminophen and fentanyl, to fentanyl and saline placebo, in terms of reduction of postoperative pain, opioid use, adverse events. The primary outcome is feasibility; secondarily, efficacy and safety will be assessed.
Design: This single-center, parallel-arm, placebo-controlled, fully blinded, randomized controlled external feasibility trial will enroll patients admitted in the neonatal intensive care unit (NICU) who have undergone major, thoracic, or abdominal surgery. Patients will be randomized 1:1, with parallel allocation to receive acetaminophen and fentanyl or fentanyl and saline placebo. All study staff, clinical staff and guardians will be blinded. As this is a pilot study, no sample size will be calculated, however; we aim to enroll 60 patients. A sample size calculation will be completed for the full RCT if it is deemed feasible from the results of this study. Patients will be followed for the day of surgery and the following 7 postoperative days (192 hours) and have their charts reviewed at 90 days.
Impact: The results of this study will be used to determine the feasibility of conducting a multi-center RCT to assess the effect of IV acetaminophen on fentanyl infusions in postoperative neonatal patients. The effect of IV acetaminophen for postoperative pain in preterm neonates has yet to be studied, this trial would generate novel insights into its efficacy. The prolonged follow-up period would also provide novel insights into recovery throughout the entire perioperative period.
- Conditions
- Pain, Postoperative, Pain
- Being tested
- Acetaminophen, Placebo
- Keywords
- acetaminophen, pain, neonate, infant, tylenol, paracetamol, postoperative, surgery
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
IV acetaminophen will be added to standard of care opioid based pain regimes.
PlaceboDrug
In control group placebo will be added to standard of care opioid based pain regimes.
| Study group | Role | What they receive |
|---|---|---|
| Comparator | Active comparator | Standard of care + IV acetaminophen:
Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of IV acetaminophen every 4 or 6 hours at weight-appropriate doses based on the patient's gestational age. Receives: Drug: Acetaminophen |
| Placebo | Placebo comparator | Standard of care + placebo:
Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of an IV saline placebo every 4 or 6 hours at a rate which would mimic their dose of acetaminophen. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Mean number of patients randomized per month
Measured: through study completion, an average of 1.5 years
Follow up rate
Number of patients followed in completion from postoperative day 0 to 7
Measured: 90 days
Medication compliance
Number of patients who received at least 80% of doses of study drugs at the correct dose and interval
Measured: 7 days
Blinding index
Responses of nurse's physician's, and research staff's guess of group assignment (control vs treatment) compared to actual group assignment
Measured: 7 days
Secondary outcomes (11)
Postoperative Pain
Measured by the N-PASS Pain Scale as units on the scale (scale ranges from 0-10)
Measured: every 6 hours for entire study period (7 days after surgery)
Daily fentanyl consumption
Fentanyl consumption will be recorded for each patient for each 24-hour period in the study period. Will be recorded in mcg/kg.
Measured: daily for 7 days
Total fentanyl consumption
Daily fentanyl consumption will be added together for the entire study period to determine the total amount of fentanyl consumed in mcg/kg.
Measured: 7 days
Daily Consumption of other analgesics
Consumption of other analgesics will be recorded for each patient for each 24-hour period in the study period. Will be recorded in mg or mcg /kg.
Measured: daily for 7 days
Total consumption of other analgesics
Daily consumption of other analgesics will be added together for the entire study period to determine the total amount of fentanyl consumed in mg or mcg/kg.
Measured: 7 days
Invasive ventilation
Length of time requiring intubation
Measured: 90 days
Non-invasive ventilation
Length of time requiring CPAP, BiPAP, or supplemental oxygen
Measured: 90 days
Enteral feeds
Time to first enteral feeds and time to full enteral feeds (using NICU's calculated goal feed)
Measured: 90 days
Bowel movement
Time to first bowel movement
Measured: 90 days
Glycerin suppository use
Number of patients requiring one or more glycerin suppositories
Measured: 90 days
Length of stay
with discharge destination
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start17 Apr 2023
- Primary completionAug 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Model description
- Patients will be randomized to the control or comparator group. There will be 60 patients enrolled, with 30 patients per arm.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Victoria Archer, McMaster Children's Hospital
- Investigators
- Mark Walton, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05678244
- Sponsor's protocol ID
- 14887-GRA
- Acronym
- IVA POP NICU
- Status last verified
- Apr 2023
- First submitted
- 6 Dec 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Archer VA, Samiee-Zafarghandy S, Farrokyhar F, Briatico D, Braga LH, Walton JM. Intravenous acetaminophen for postoperative pain in the neonatal intensive care unit: A protocol for a pilot randomized controlled trial (IVA POP). PLoS One. 2023 Nov 20;18(11):e0294519. doi: 10.1371/journal.pone.0294519. eCollection 2023.
PubMed 37983228
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Acetaminophen For Postoperative Pain in the Neonatal Intensive Care Unit: A Feasibility Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05678244
- Acronym / sponsor ID
- IVA POP NICU / 14887-GRA
- Conditions
- Pain, Postoperative, Pain
- Keywords
- acetaminophen, pain, neonate, infant, tylenol, paracetamol, postoperative, surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McMaster Children's HospitalUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 10 Jan 2023 (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.
The goal of this pilot randomized clinical trial is to determine the effect of the addition of IV acetaminophen to opioid-based pain regimes for infants admitted to the neonatal intensive care unit (NICU) after surgery.
This is a pilot trial; the main goals are to make sure our study methods work before performing a larger study.
The main clinical aims are:
- Determine if adding IV acetaminophen reduces pain
- Determine if adding IV acetaminophen reduces opioid use
- Determine if adding IV acetaminophen reduces complications
Participants will be randomized to two groups:
Comparator: Fentanyl and IV acetaminophen Control: Fentanyl and placebo
Patients will receive either IV acetaminophen or placebo at regular intervals for seven days after surgery. Patients will be followed daily during that period. Charts will be reviewed at 90-days for final outcomes.
Detailed description
Purpose: Opioid use in neonates is associated with short and long-term adverse events. Multi-modal pain control offers the ability to control pain while reducing opioid exposure. This topic has been relatively unexamined in preterm and term neonates. Specifically, this trial aims to evaluate the effect of adding IV acetaminophen to standard opioid-based pain regimes in neonates in the neonatal intensive care unit (NICU) undergoing major abdominal and thoracic surgery.
Objectives: The primary aim of the proposed study is to determine the feasibility and cost of conducting a multicenter, randomized control trial to compare the efficacy of IV acetaminophen and fentanyl, to fentanyl and saline placebo, in terms of reduction of postoperative pain, opioid use, adverse events. The primary outcome is feasibility; secondarily, efficacy and safety will be assessed.
Design: This single-center, parallel-arm, placebo-controlled, fully blinded, randomized controlled external feasibility trial will enroll patients admitted in the neonatal intensive care unit (NICU) who have undergone major, thoracic, or abdominal surgery. Patients will be randomized 1:1, with parallel allocation to receive acetaminophen and fentanyl or fentanyl and saline placebo. All study staff, clinical staff and guardians will be blinded. As this is a pilot study, no sample size will be calculated, however; we aim to enroll 60 patients. A sample size calculation will be completed for the full RCT if it is deemed feasible from the results of this study. Patients will be followed for the day of surgery and the following 7 postoperative days (192 hours) and have their charts reviewed at 90 days.
Impact: The results of this study will be used to determine the feasibility of conducting a multi-center RCT to assess the effect of IV acetaminophen on fentanyl infusions in postoperative neonatal patients. The effect of IV acetaminophen for postoperative pain in preterm neonates has yet to be studied, this trial would generate novel insights into its efficacy. The prolonged follow-up period would also provide novel insights into recovery throughout the entire perioperative period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to the control or comparator group. There will be 60 patients enrolled, with 30 patients per arm.
| Arm | Type | Receives |
|---|---|---|
| Comparator | Active comparator | Drug: AcetaminophenStandard of care + IV acetaminophen: Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of IV acetaminophen every 4 or 6 hours at weight-appropriate doses based on the patient's gestational age. |
| Placebo | Placebo comparator | Drug: PlaceboStandard of care + placebo: Baseline fentanyl infusion, with dosage escalations, deescalations, and additional boluses and analgesics (excluding oral or rectal acetaminophen) determined by the patient's physician (this represents standard of care at this institution) with the addition of an IV saline placebo every 4 or 6 hours at a rate which would mimic their dose of acetaminophen. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates, admitted to McMaster Children's Hospital NICU
- Has had major open, thoracic or abdominal surgery (see appendix 1, table 6).
- Informed consent obtained from guardian(s)
Key exclusion criteria (15 listed)
- Hepatic dysfunction
- Renal dysfunction
- Allergy or intolerance to acetaminophen or fentanyl
- Acetaminophen administration within 24 hours of the end of surgery
- Nerve blocks or epidurals
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 |
|---|---|---|
| AcetaminophenIV acetaminophen will be added to standard of care opioid based pain regimes. | Drug | Comparator |
| PlaceboIn control group placebo will be added to standard of care opioid based pain regimes. | Drug | Placebo |
Primary outcome
Recruitment rate
Time frame: through study completion, an average of 1.5 years
Mean number of patients randomized per month
Follow up rate
Time frame: 90 days
Number of patients followed in completion from postoperative day 0 to 7
Medication compliance
Time frame: 7 days
Number of patients who received at least 80% of doses of study drugs at the correct dose and interval
Blinding index
Time frame: 7 days
Responses of nurse's physician's, and research staff's guess of group assignment (control vs treatment) compared to actual group assignment
11 secondary outcomes
Postoperative Pain
Time frame: every 6 hours for entire study period (7 days after surgery)
Daily fentanyl consumption
Time frame: daily for 7 days
Total fentanyl consumption
Time frame: 7 days
Daily Consumption of other analgesics
Time frame: daily for 7 days
Total consumption of other analgesics
Time frame: 7 days
Invasive ventilation
Time frame: 90 days
Non-invasive ventilation
Time frame: 90 days
Enteral feeds
Time frame: 90 days
Bowel movement
Time frame: 90 days
Glycerin suppository use
Time frame: 90 days
Length of stay
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Derived from this study: PubMed 37983228Archer VA, Samiee-Zafarghandy S, Farrokyhar F, Briatico D, Braga LH, Walton JM. Intravenous acetaminophen for postoperative pain in the neonatal intensive care unit: A protocol for a pilot randomized controlled trial (IVA POP). PLoS One. 2023 Nov 20;18(11):e0294519. doi: 10.1371/journal.pone.0294519. eCollection 2023.
- Individual participant dataSharing planned: No
Related trials for Pain, Postoperative
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
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.
Mark Walton, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acetaminophen in people with Pain, Postoperative and Pain, run by McMaster Children's Hospital at 1 site in Canada.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 25 Apr 2023. 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 Canada. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Victoria Archer, MD (506-721-9285, vicki.archer@medportal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: through study completion, an average of 1.5 years). The study lists 4 primary outcomes in all. 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 NCT05678244, which also lists 1 linked publication.
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 25 Apr 2023.