Pain Score ReductionNCT06638086
Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates
A study testing Acetaminophen Suppositories and Acetaminophen Injection in people with Pain Score Reduction and Effectiveness of Acetaminophen, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. Read more about this study
- Who is it for?
- Ages 1 hour to 28 days
- Conditions the study is for
- Pain Score Reduction, Effectiveness of Acetaminophen, Postoperative Pain Management in Neonates
- What is being tested?
- Acetaminophen Suppositories and Acetaminophen Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jan 2023to 10 Jan 2024
- Phase
- Interventional
- 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 1 hour to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All post-operative neonates requiring acetaminiphen as analgesia.
Who cannot join
- All neonates requiring any other kind of Pain relief medication (Nerve block or local analgesia)
- All neonates in neonatal ICU
- All neonates with central venous line in place
- All neonates that are on ventilatory support
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Department of Pediatric Surgery,Holy Family Hospital
Rawalpindi, Punjab Province, 46000
About this study
Official title: Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates; A Randomised Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. The main questions the study seeks to answer are:
Does IV acetaminophen provide better pain relief compared to rectal administration in neonates? What is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? The study compares 32 neonates receiving IV acetaminophen to 32 neonates administered rectal acetaminophen. Both routes are administered at equivalent bioavailable doses to ensure a fair comparison.
Read the detailed description
This randomized controlled trial investigates the comparative effectiveness of intravenous (IV) versus rectal administration of acetaminophen for managing postoperative pain in neonates. Neonates, due to their limited physiological reserves and underdeveloped metabolic systems, require precise pain management strategies to prevent potential developmental delays or adverse effects. Acetaminophen, a commonly used analgesic in neonatal care, is metabolized primarily by the liver and excreted via the kidneys. However, its pharmacokinetics vary significantly based on the route of administration, making it important to evaluate which method offers more reliable pain relief.
The study includes 64 term neonates who underwent surgery and are expected to require pain relief for at least 12 hours. Preterm and preoperative neonates are excluded. The neonates were randomized into two groups: one receiving acetaminophen intravenously (15 mg/kg) and the other rectally (40 mg/kg), ensuring similar concentrations at the effect site.
Key variables include rescue analgesia requirements, time to rescue analgesia, and changes in pain scores. Pain relief efficacy is measured by pain score changes, and any need for additional analgesia is recorded.
This study will provide valuable insights into the optimal route for administering acetaminophen in neonates.
- Conditions
- Pain Score Reduction, Effectiveness of Acetaminophen, Postoperative Pain Management in Neonates, Rescue Analgesia, Neonatal Patient
- Being tested
- Acetaminophen Suppositories, Acetaminophen Injection
- Keywords
- Neonatal analgesia protocols, Neonatal care, Pain score reduction, Neonatal pain management, Acetaminophen in neonates, Pediatric surgery pain relief
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetaminophen SuppositoriesDrug
Also called Napa Suppositories
Per rectal suppositories
Acetaminophen InjectionDrug
Also called Provase
Intra-venous injection
| Study group | Role | What they receive |
|---|---|---|
| Per-rectal group | Experimental | These neonates received Acetaminophen per rectally at dose of 40 mg/kg. Receives: Drug: Acetaminophen Suppositories |
| Intra-vanous group | Active comparator | These neonates received intravenous Acetaminophen at dose of 15 mg/kg. Receives: Drug: Acetaminophen Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in pain score
"Bernese Pain Scale for Neonates" will be used consisting of total score of 27
Measured: 0 to 6 hours
Time for rescue analgesia
time will be measured and compared
Measured: 0 to 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start10 Jan 2023
- Primary completion10 Jan 2024
- Study completion10 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Pain Score ReductionStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The interventional study model for this article is a Parallel Assignment model. In this study, neonates are randomly assigned to one of two groups: one group receives intravenous (IV) acetaminophen, and the other group receives rectal acetaminophen. The outcomes, such as the need for rescue analgesia, time to rescue analgesia, and reduction in pain scores, are then compared between these two parallel groups to assess the effectiveness of the different administration routes for managing postoperative pain in neonates.
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hasnain Aslam, Rawalpindi Medical College
- Investigators
- Ali Raza Chaudhry, MBBS, MS, Study director, Rawalpindi Medical CollegeMudassar Fiaz Gondal, MBBS, MS, Study chair, Rawalpindi Medical CollegeHasnain Aslam, MBBS, Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06638086
- Sponsor's protocol ID
- RMU-RRF-SUR-008-23
- Status last verified
- Oct 2024
- First submitted
- 8 Oct 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Grunau RE, Whitfield MF, Petrie-Thomas J, Synnes AR, Cepeda IL, Keidar A, Rogers M, Mackay M, Hubber-Richard P, Johannesen D. Neonatal pain, parenting stress and interaction, in relation to cognitive and motor development at 8 and 18 months in preterm infants. Pain. 2009 May;143(1-2):138-46. doi: 10.1016/j.pain.2009.02.014.
PubMed 19307058Cuzzolin L, Antonucci R, Fanos V. Paracetamol (acetaminophen) efficacy and safety in the newborn. Curr Drug Metab. 2013 Feb;14(2):178-85.
PubMed 22935063Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007.
PubMed 19192939Walls L, Baker CF, Sarkar S. Acetaminophen-induced hepatic failure with encephalopathy in a newborn. J Perinatol. 2007 Feb;27(2):133-5. doi: 10.1038/sj.jp.7211641.
PubMed 17262050Hansen TG, O'Brien K, Morton NS, Rasmussen SN. Plasma paracetamol concentrations and pharmacokinetics following rectal administration in neonates and young infants. Acta Anaesthesiol Scand. 1999 Sep;43(8):855-9. doi: 10.1034/j.1399-6576.1999.430813.x.
PubMed 10492416Anderson BJ, van Lingen RA, Hansen TG, Lin YC, Holford NH. Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis. Anesthesiology. 2002 Jun;96(6):1336-45. doi: 10.1097/00000542-200206000-00012.
PubMed 12170045Capici F, Ingelmo PM, Davidson A, Sacchi CA, Milan B, Sperti LR, Lorini L, Fumagalli R. Randomized controlled trial of duration of analgesia following intravenous or rectal acetaminophen after adenotonsillectomy in children. Br J Anaesth. 2008 Feb;100(2):251-5. doi: 10.1093/bja/aem377.
PubMed 18211998
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Of Intravenous Vs Rectal Acetaminophen For Pain Management In Post Operative Neonates; A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06638086
- Acronym / sponsor ID
- RMU-RRF-SUR-008-23
- Conditions
- Pain Score Reduction, Effectiveness of Acetaminophen, Postoperative Pain Management in Neonates, Rescue Analgesia, Neonatal Patient
- Keywords
- Neonatal analgesia protocols, Neonatal care, Pain score reduction, Neonatal pain management, Acetaminophen in neonates, Pediatric surgery pain relief
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 10 Jan 2024 (actual)
- First posted
- 15 Oct 2024 (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.
This randomized controlled trial aims to evaluate the effectiveness of intravenous (IV) versus rectal acetaminophen for postoperative pain management in neonates. The study includes postoperative term neonates who require analgesia for at least 12 hours. The main questions the study seeks to answer are:
Does IV acetaminophen provide better pain relief compared to rectal administration in neonates? What is the time to rescue analgesia and the efficacy of pain score reduction between these two routes? The study compares 32 neonates receiving IV acetaminophen to 32 neonates administered rectal acetaminophen. Both routes are administered at equivalent bioavailable doses to ensure a fair comparison.
Detailed description
This randomized controlled trial investigates the comparative effectiveness of intravenous (IV) versus rectal administration of acetaminophen for managing postoperative pain in neonates. Neonates, due to their limited physiological reserves and underdeveloped metabolic systems, require precise pain management strategies to prevent potential developmental delays or adverse effects. Acetaminophen, a commonly used analgesic in neonatal care, is metabolized primarily by the liver and excreted via the kidneys. However, its pharmacokinetics vary significantly based on the route of administration, making it important to evaluate which method offers more reliable pain relief.
The study includes 64 term neonates who underwent surgery and are expected to require pain relief for at least 12 hours. Preterm and preoperative neonates are excluded. The neonates were randomized into two groups: one receiving acetaminophen intravenously (15 mg/kg) and the other rectally (40 mg/kg), ensuring similar concentrations at the effect site.
Key variables include rescue analgesia requirements, time to rescue analgesia, and changes in pain scores. Pain relief efficacy is measured by pain score changes, and any need for additional analgesia is recorded.
This study will provide valuable insights into the optimal route for administering acetaminophen in neonates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The interventional study model for this article is a Parallel Assignment model. In this study, neonates are randomly assigned to one of two groups: one group receives intravenous (IV) acetaminophen, and the other group receives rectal acetaminophen. The outcomes, such as the need for rescue analgesia, time to rescue analgesia, and reduction in pain scores, are then compared between these two parallel groups to assess the effectiveness of the different administration routes for managing postoperative pain in neonates.
| Arm | Type | Receives |
|---|---|---|
| Per-rectal group | Experimental | Drug: Acetaminophen SuppositoriesThese neonates received Acetaminophen per rectally at dose of 40 mg/kg. |
| Intra-vanous group | Active comparator | Drug: Acetaminophen InjectionThese neonates received intravenous Acetaminophen at dose of 15 mg/kg. |
Who may qualify
- Ages
- 1 hour to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All post-operative neonates requiring acetaminiphen as analgesia.
Key exclusion criteria (4 listed)
- All neonates requiring any other kind of Pain relief medication (Nerve block or local analgesia)
- All neonates in neonatal ICU
- All neonates with central venous line in place
- All neonates that are on ventilatory support
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 |
|---|---|---|
| Acetaminophen SuppositoriesAlso: Napa SuppositoriesPer rectal suppositories | Drug | Per-rectal group |
| Acetaminophen InjectionAlso: ProvaseIntra-venous injection | Drug | Intra-vanous group |
Primary outcome
change in pain score
Time frame: 0 to 6 hours
"Bernese Pain Scale for Neonates" will be used consisting of total score of 27
Time for rescue analgesia
Time frame: 0 to 6 hours
time will be measured and compared
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Results publication: PubMed 19307058Grunau RE, Whitfield MF, Petrie-Thomas J, Synnes AR, Cepeda IL, Keidar A, Rogers M, Mackay M, Hubber-Richard P, Johannesen D. Neonatal pain, parenting stress and interaction, in relation to cognitive and motor development at 8 and 18 months in preterm infants. Pain. 2009 May;143(1-2):138-46. doi: 10.1016/j.pain.2009.02.014.
- Results publication: PubMed 22935063Cuzzolin L, Antonucci R, Fanos V. Paracetamol (acetaminophen) efficacy and safety in the newborn. Curr Drug Metab. 2013 Feb;14(2):178-85.
- Results publication: PubMed 19192939Duggan ST, Scott LJ. Intravenous paracetamol (acetaminophen). Drugs. 2009;69(1):101-13. doi: 10.2165/00003495-200969010-00007.
- Results publication: PubMed 17262050Walls L, Baker CF, Sarkar S. Acetaminophen-induced hepatic failure with encephalopathy in a newborn. J Perinatol. 2007 Feb;27(2):133-5. doi: 10.1038/sj.jp.7211641.
- Results publication: PubMed 10492416Hansen TG, O'Brien K, Morton NS, Rasmussen SN. Plasma paracetamol concentrations and pharmacokinetics following rectal administration in neonates and young infants. Acta Anaesthesiol Scand. 1999 Sep;43(8):855-9. doi: 10.1034/j.1399-6576.1999.430813.x.
- Results publication: PubMed 12170045Anderson BJ, van Lingen RA, Hansen TG, Lin YC, Holford NH. Acetaminophen developmental pharmacokinetics in premature neonates and infants: a pooled population analysis. Anesthesiology. 2002 Jun;96(6):1336-45. doi: 10.1097/00000542-200206000-00012.
- Results publication: PubMed 18211998Capici F, Ingelmo PM, Davidson A, Sacchi CA, Milan B, Sperti LR, Lorini L, Fumagalli R. Randomized controlled trial of duration of analgesia following intravenous or rectal acetaminophen after adenotonsillectomy in children. Br J Anaesth. 2008 Feb;100(2):251-5. doi: 10.1093/bja/aem377.
- 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.
Ali Raza Chaudhry, MBBS, MS study director
Rawalpindi Medical College
Mudassar Fiaz Gondal, MBBS, MS study chair
Rawalpindi Medical College
Hasnain Aslam, MBBS principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen Suppositories and Acetaminophen Injection in people with Pain Score Reduction and Effectiveness of Acetaminophen, run by Rawalpindi Medical College at 1 site in Pakistan.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 15 Oct 2024. 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 Pakistan. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in pain score (time frame: 0 to 6 hours). The study lists 2 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 NCT06638086, which also lists 7 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 15 Oct 2024.