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Postoperative PainNCT01140724

Personalizing Perioperative Analgesia in Children

An observational study of Postoperative Pain, run by Senthil Sadhasivam at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In the United States alone, each year approximately 5 million children undergo painful surgery, many of them experience serious side-effects with opioids and inadequate pain relief. Read more about this study

Who is it for?
Ages 3 to 15 years
Conditions the study is for
Postoperative Pain
How many people
1,200 participants
Where
1 siteUnited States
Study dates
7 Feb 2022to 25 Dec 2027
Phase
Observational
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 3 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Children, 3-15 years of age, undergoing tonsillectomy or adenotonsillectomy at the Riley Hospital for Children, who have consented to participate in an observational clinical study as approved by the IU IRB, protocol # 1707325115.

Who may be able to join

  • boys and girls,
  • 3-15 years of age,
  • all races,
  • American Society of Anesthesiologists (ASA) physical status 1,2, and 3,
  • children with history of significant snoring suggestive of obstructive sleep apnea (OSA),
  • Scheduled for tonsillectomy (T) or tonsillectomy and adenoidectomy (T and A).

Who cannot join

  • allergic to study medications
  • developmental delay,
  • liver and renal diseases,
  • preoperative pain requiring analgesics,
  • children who have problems with pupil or pupillary reaction due to disease
  • preoperative medications influencing pupillary size
Show all 13Show fewer
  • non-English speaking participants and families
  • Body Mass Index ≥30
  • Participants undergoing additional procedures during surgery
  • Children with certain cardiac conditions
  • Children with severe lung disease
  • Children with a history of seizures currently treated on medication
  • Children with psychiatric/psychological conditions for which patient currently takes medication

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UPMC Children's Hospital

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

About this study

Official title: Predicting Perioperative Opioid Adverse Effects and Personalizing Analgesia in Children

In the United States alone, each year approximately 5 million children undergo painful surgery, many of them experience serious side-effects with opioids and inadequate pain relief. Safe and effective analgesia is an important unmet critical medical need in children and its continued existence is an important perioperative safety and economic problem. Inadequate pain relief and serious side effects from perioperative opioids occur frequently in up to 50% of children. Morphine, the most commonly used perioperative opioid, has a narrow therapeutic index and large inter-patient variations in analgesic response and serious side effects. Frequent inter-individual variations in responses to morphine have significant clinical and economic impact with inadequate pain relief at one end of the spectrum of responses and serious adverse effects such as respiratory depression at the other end. Much of the inter-individual variability in response to a dose of morphine following surgical procedures can be explained by single nucleotide polymorphisms (SNPs) in a subset of the genes that encode proteins involved in pain mechanisms and opioid pathway.

Read the detailed description

Measures and Procedures: Participants will receive standard care, standard anesthetic and an intraoperative dose of morphine per the clinical team.

Research procedures will include:

  1. Blood draws for genotyping candidate genes and exploratory genes
  2. Standardized PACU (post anesthesia care unit) Protocol: Subjective pain assessments: Numerical Rating Scale (NRS) 0 to 10. Objective assessment with FLACC (facial expression; leg movement; activity; cry; and consolability) scale, 0-10.
  3. Significant postoperative pain will be managed in the PACU with rescue doses of morphine and opioids by the clinical team. Analgesic interventions and morphine requirements are collected
  4. Effects of opioids on pupil measures
  5. Respiratory response to 5% carbon dioxide preoperatively and postoperatively (first 350 patients only). Another measure of end tidal carbon dioxide will be implemented when the device is clinically available.
  6. Serial blood draws for morphine pharmacokinetic modeling (through subject #351).
  7. Opioid adverse effects in PACU and at home.
Keywords
pain, genes, morphine, respiratory depression, tonsillectomy, children, Opioid adverse effects, Pharmacogenetics of morphine, Pharmacokinetics of morphine, Personalizing analgesia
Medical subject headings
Pain, Postoperative, Pain, Respiratory Insufficiency

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a higher susceptibility to pain and morphine requirement.

    Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a relationship to more pain and need for a higher morphine requirement.

    Measured: After tonsillectomy surgery (duration of post anesthesia care unit stay)

Secondary outcomes (1)

  1. Evaluate relationship of pupil reaction and response to 5% carbon dioxide to adverse effects of morphine

    Measured: After tonsillectomy surgery (duration of post anesthesia care unit stay)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2010 (estimated)
  2. Study start7 Feb 2022
  3. Primary completion16 Aug 2027 (estimated)
  4. Study completion25 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01140724
Sponsor's protocol ID
STUDY21070173
Other IDs
R01HD089458
Status last verified
Jun 2026
First submitted
8 Jun 2010
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Packiasabapathy S, Zhang X, Ding L, Aruldhas BW, Pawale D, Sadhasivam S. Quantitative Pupillometry as a Predictor of Pediatric Postoperative Opioid-Induced Respiratory Depression. Anesth Analg. 2021 Oct 1;133(4):991-999. doi: 10.1213/ANE.0000000000005579.

    PubMed 34029273

  • Hahn D, Fukuda T, Euteneuer JC, Mizuno T, Vinks AA, Sadhasivam S, Emoto C. Influence of MRP3 Genetics and Hepatic Expression Ontogeny for Morphine Disposition in Neonatal and Pediatric Patients. J Clin Pharmacol. 2020 Aug;60(8):992-998. doi: 10.1002/jcph.1592. Epub 2020 Feb 24.

    PubMed 32090339

  • Chidambaran V, Venkatasubramanian R, Zhang X, Martin LJ, Niu J, Mizuno T, Fukuda T, Meller J, Vinks AA, Sadhasivam S. ABCC3 genetic variants are associated with postoperative morphine-induced respiratory depression and morphine pharmacokinetics in children. Pharmacogenomics J. 2017 Mar;17(2):162-169. doi: 10.1038/tpj.2015.98. Epub 2016 Jan 26.

    PubMed 26810133

  • Sadhasivam S, Zhang X, Chidambaran V, Mavi J, Pilipenko V, Mersha TB, Meller J, Kaufman KM, Martin LJ, McAuliffe J. Novel associations between FAAH genetic variants and postoperative central opioid-related adverse effects. Pharmacogenomics J. 2015 Oct;15(5):436-42. doi: 10.1038/tpj.2014.79. Epub 2015 Jan 6.

    PubMed 25558980

  • Sadhasivam S, Chidambaran V, Olbrecht VA, Costandi A, Clay S, Prows CA, Zhang X, Martin LJ. Opioid-related adverse effects in children undergoing surgery: unequal burden on younger girls with higher doses of opioids. Pain Med. 2015 May;16(5):985-97. doi: 10.1111/pme.12660. Epub 2014 Dec 17.

    PubMed 25521773

  • Sadhasivam S, Chidambaran V, Olbrecht VA, Esslinger HR, Zhang K, Zhang X, Martin LJ. Genetics of pain perception, COMT and postoperative pain management in children. Pharmacogenomics. 2014 Feb;15(3):277-84. doi: 10.2217/pgs.13.248.

    PubMed 24533707

  • Prows CA, Zhang X, Huth MM, Zhang K, Saldana SN, Daraiseh NM, Esslinger HR, Freeman E, Greinwald JH, Martin LJ, Sadhasivam S. Codeine-related adverse drug reactions in children following tonsillectomy: a prospective study. Laryngoscope. 2014 May;124(5):1242-50. doi: 10.1002/lary.24455. Epub 2013 Nov 13.

    PubMed 24122716

  • Sadhasivam S, Krekels EH, Chidambaran V, Esslinger HR, Ngamprasertwong P, Zhang K, Fukuda T, Vinks AA. Morphine clearance in children: does race or genetics matter? J Opioid Manag. 2012 Jul-Aug;8(4):217-26. doi: 10.5055/jom.2012.0119.

    PubMed 22941849

  • Sadhasivam S, Chidambaran V, Ngamprasertwong P, Esslinger HR, Prows C, Zhang X, Martin LJ, McAuliffe J. Race and unequal burden of perioperative pain and opioid related adverse effects in children. Pediatrics. 2012 May;129(5):832-8. doi: 10.1542/peds.2011-2607. Epub 2012 Apr 23.

    PubMed 22529273

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain, run by Senthil Sadhasivam 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 6 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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. 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?

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?

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?

Look at polymorphisms in genes that regulate pain perception, opioid transport and opioid receptor signaling to see if there is a higher susceptibility to pain and morphine requirement. (time frame: After tonsillectomy surgery (duration of post anesthesia care unit stay)). 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 NCT01140724, which also lists 9 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 17 Sep 2026.

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