Postoperative PainNCT03854604
Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients.
An observational study of Postoperative Pain, run by Cairo University at 3 sites in Egypt.
Trial summary
It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult. Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. Read more about this study
- Who is it for?
- Ages 3 to 7 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- postoperative pain assessment
- How many people
- 50 participants
- Where
- 3 sitesEgypt
- Study dates
- 20 Mar 2019to 20 Sep 2019
- Phase
- Observational
- 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 3 to 7 years
- All sexes
- No healthy volunteers
- Child
Study population: Children 3-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included
Who may be able to join
- ASA physical status I-II
- Age 3 to 7 years
- Children undergoing adenotonsillectomy.
Who cannot join
- Parents' refusal.
- Children with behavioral changes
- Children with physical developmental delay
- Children on treatment with sedative or anticonvulsant.
Trial locations and contacts
3 sites in 1 country.
Egypt3 sites
Abeer Ahmed
Cairo, 002211
Kasr Alainy Faculty of Medicine - Cairo university
Cairo, 00225
Anesthesia department - Faculty of medicine- Cairo University
Cairo
About this study
Official title: Evaluation of Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients Undergoing Adenotonsillectomy. An Observational Study.
It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult.
Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation.
Read more
The sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation.
In the current study, investigators hypothesise that the PI could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.
- Conditions
- Postoperative Pain
- Being tested
- postoperative pain assessment
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative pain assessmentOther
evaluation of the efficacy of PI as an objective measure for postoperative pain assessment in pediatric population undergoing adenotonsillectomy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between postoperative (Children's Hospital of Eastern Ontario Scale ) CHEOPS score and postoperative perfusion index.
Measured: the time span between arrival to PACU and for at least two hours postoperative
Secondary outcomes (1)
validity of perfusion index to predict postoperative pain and the need of rescue analgesia
Measured: he time span between arrival to PACU and for at least two hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2019
- Study start20 Mar 2019
- Primary completion20 Jun 2019
- Study completion20 Sep 2019
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03854604
- Sponsor's protocol ID
- N-110-2018
- Status last verified
- Aug 2020
- First submitted
- 16 Feb 2019
- Last updated
- 1 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahmed A, Lotfy A, Elkholy J, Abdelhamid B, Ollaek M. Perfusion index as an objective measure of postoperative pain in children undergoing adenotonsillectomy: a cohort study. J Clin Monit Comput. 2022 Jun;36(3):795-801. doi: 10.1007/s10877-021-00710-3. Epub 2021 Apr 23.
PubMed 33891250
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perfusion Index as an Objective Measure for Postoperative Pain Assessment in Pediatric Patients Undergoing Adenotonsillectomy. An Observational Study.
- ClinicalTrials.gov ID
- NCT03854604
- Acronym / sponsor ID
- N-110-2018
- Conditions
- Postoperative Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Mar 2019 (actual)
- Primary completion
- 20 Jun 2019 (actual)
- Study completion
- 20 Sep 2019 (actual)
- First posted
- 26 Feb 2019 (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.
It has been demonstrated that infants and children experience pain in a similar manner to adults, however it used to be undertreated when compared to adult.
Perfusion Index (PI) derived from pulse plethysmography waveform, represents a ratio of pulsatile signal (during arterial inflow) to non-pulsatile signal. PI can represent the peripheral perfusion dynamics due to change of peripheral vasomotor tone. Low PI values suggest peripheral vasoconstriction and high PI values suggest peripheral vasodilation.
The sympathetic nervous system is inherently involved in the pathophysiological responses evoked by painful stimulation.
In the current study, investigators hypothesise that the PI could be a good objective tool for assessment of postoperative pain in children undergoing adenotonsillectomy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children 3-7 years, ASA physical status I or II, undergoing Adenotonsillectomy will be included
Key inclusion criteria (3 listed)
- ASA physical status I-II
- Age 3 to 7 years
- Children undergoing adenotonsillectomy.
Key exclusion criteria (4 listed)
- Parents' refusal.
- Children with behavioral changes
- Children with physical developmental delay
- Children on treatment with sedative or anticonvulsant.
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 |
|---|---|---|
| postoperative pain assessmentevaluation of the efficacy of PI as an objective measure for postoperative pain assessment in pediatric population undergoing adenotonsillectomy. | Other | – |
Primary outcome
Correlation between postoperative (Children's Hospital of Eastern Ontario Scale ) CHEOPS score and postoperative perfusion index.
Time frame: the time span between arrival to PACU and for at least two hours postoperative
1 secondary outcome
validity of perfusion index to predict postoperative pain and the need of rescue analgesia
Time frame: he time span between arrival to PACU and for at least two hours postoperative
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 1 Sep 2020.
- Derived from this study: PubMed 33891250Ahmed A, Lotfy A, Elkholy J, Abdelhamid B, Ollaek M. Perfusion index as an objective measure of postoperative pain in children undergoing adenotonsillectomy: a cohort study. J Clin Monit Comput. 2022 Jun;36(3):795-801. doi: 10.1007/s10877-021-00710-3. Epub 2021 Apr 23.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Cairo University at 3 sites in Egypt.
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 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 1 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
Correlation between postoperative (Children's Hospital of Eastern Ontario Scale ) CHEOPS score and postoperative perfusion index. (time frame: the time span between arrival to PACU and for at least two hours postoperative). 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 NCT03854604, 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 1 Sep 2020.