Pain, PostoperativePhase 4NCT03681574
Gabapentin as Preanesthetic Medication to Fast Procedures in Pediatric´s Oncology
A Phase 4 study testing GABA 15mg/kg Group and GABA 30mg/kg Group in people with Pain, Postoperative and Agitation States as Acute Reaction to Exceptional Stress, run by Hospital Infantil Albert Sabin at 1 site in Brazil.
Trial summary
This study is a clinical trial, prospective, randomized and double-blinded. Placebo, Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Pain, Postoperative, Agitation States as Acute Reaction to Exceptional Stress, Anesthesia
- What is being tested?
- GABA 15mg/kg Group and GABA 30mg/kg Group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jul 2017to 1 Aug 2018
- 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 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cancer or under investigation for cancer.
- Children between 1 and 6 years.
- Previously submitted to oncologic procedures, e.g. myelogram or puncture lumbar.
Who cannot join
- Cardiac disease.
- Pulmonary disease.
- Renal disease.
- Neurological disease.
- Any allergies.
- Refusal of parents, caregivers or patients to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Gabapentin as Preanesthetic Medication in Oncologic Children Undergoing in Fast Procedures With Sevofluran
This study is a clinical trial, prospective, randomized and double-blinded. Placebo, Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years.
Read the detailed description
Gabapentin syrup at 15 mg/kg and at 30 mg/kg was administered to reduce the agitation before and after oncologic procedures (myelogram or lumbar puncture) in children among 1 and 6 years. Three groups were compared: the control group received placebo, the other two groups received gabapentin at 15mg/kg or at 30mg/kg. All patients received the same protocols (anesthesia and analgesia). Anesthesia protocol used was induction with sevoflurane 8% plus N2O 50% and oxygen, maintenance with sevoflurane 4%. We provided local analgesia with 5% lidocaine creme before the procedure. If it was required, dipyrone 10mg/kg every 6 hours was given as rescue analgesia. To prevent post-operative vomit, ondasentron 0,1mg/kg was administered when intrathecal chemotherapy. The mYPAS scale was used to evaluate preoperative anxiety at several moments: at basal, at after 1-hour administration, at separation from parents, and at induction. The PAED scale was applied after 30 minutes of procedure to evaluate postoperative agitation. The CHIPPS scale was used to assess postoperative pain. The frequency of vomits was recorded for 8 hours after the procedure finished.
- Conditions
- Pain, Postoperative, Agitation States as Acute Reaction to Exceptional Stress, Anesthesia, Vomiting
- Being tested
- Placebo Group, GABA 15mg/kg Group, GABA 30mg/kg Group
- Keywords
- pediatric, gabapentin, agitation, induction
- Medical subject headings
- Pain, Postoperative, Vomiting, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo GroupDrug
Also called Lumbar puncture, Myelogram
Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive placebo concentrate.
GABA 15mg/kg GroupDrug
Also called Lumbar puncture, Myelogram
Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 15mg/kg.
GABA 30mg/kg GroupDrug
Also called Lumbar puncture, Myelogram
Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 30mg/kg.
| Study group | Role | What they receive |
|---|---|---|
| Placebo Group | Experimental | The placebo group will receive placebo concentrate orally (0.3 mL/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture. Receives: Drug: Placebo Group |
| GABA 15mg/kg Group | Experimental | The GABA 15mg/kg group will receive gabapentin syrup orally (15 mg/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture. Receives: Drug: GABA 15mg/kg Group |
| GABA 30mg/kg Group | Experimental | The GABA 30mg/kg group will receive gabapentin syrup orally (30 mg/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture. Receives: Drug: GABA 30mg/kg Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects.
Children, ranging from 1 to 6 years old, will receive drugs (placebo, gabapentin 15mg/kg or 30mg/kg) 1 to 2 hours before the oncologic procedure (myelogram and/ or puncture lumbar). They will be submitted to the same general anesthesia protocol (sevoflurane 8% plus N2O and oxygen) and postoperative analgesia. All patients will be observed for changes in the Modified Yale Preoperative Anxiety Scale (mYPAS) at baseline (right before drug administration), at 1 hour after group administration, at the separation from parents, and at anesthetic induction time. The mYPAS scale is a compilation of 5 subscales: activity (0 to 4 points), vocalizations (0 to 6 points), emotional expressivity (0 to 4 points), state of apparent arousal (0 to 4 points), and use of parent (0 to 4 points). All scores are summed up, divided by 4, and then multiplied by 100. Total scores above 30 points are interpreted as a patient with anxiety, which would represent a worse outcome.
Measured: 8 hours
Secondary outcomes (5)
Percentage of sevoflurane consumption in patients over anesthetic induction.
Patients will be submitted to the same general anesthesia protocol, receiving sevoflurane 8% plus N2O and oxygen prior to the procedure. We will measure the percentage of sevoflurane ended-expired.
Measured: 8 hours
Level of emergence delirium and agitation in children at post-operative through Paediatric Anaesthesia Emergence Delirium.
After the procedure, all patients will be observed for change in the Paediatric Anaesthesia Emergence Delirium (PAED 0 to 20 points) scale. Score changes will be assessed at baseline (right after the procedure), and at 30 minutes the procedure has finished. Each criterion is assessed through the event frequency, e.g. "eye contact" that "never" occurs corresponds to score 4. The range goes from "never" (4 points) up to "always" (0 points) for positive behavior criteria. Those are "make contact with the caregiver", "actions are purposeful", and "aware of surroundings". Negative behavior criteria range from "never" (0 points) up to "always" (4 points). Those are "restlessness" and "inconsolable". All subscores are summed up into a total score. Total scores above 10 points are interpreted as a patient with emergence delirium, which would indicate a worse outcome.
Measured: 1 hour
Frequency of post-operative vomits.
All patients will be evaluated number of vomits occurrence for 8 hours after procedure.
Measured: 8 hours
Anesthetic induction time in seconds.
Patients will be submitted to the same general anesthesia protocol, receiving sevoflurane 8% plus N2O and oxygen prior to the procedure. We will record the time, in seconds, when patients lose their consciousness and corneal reflex.
Measured: 8 hours
Levels of postoperative pain in children through Children and Infants Postoperative Pain Scale (CHIPPS).
After the procedure, all patients will be observed for changes in the Children and Infants Postoperative Pain Scale (CHIPPS) scores. Score changes will be assessed at baseline (right after the procedure), and at 30 minutes the procedure has finished. The score ranges from 0 (Behavior not present) to 2 (Intense behavior), to be assessed in each of the following indicators: "crying", "facial expression", "posture of the trunk", "posture of legs", and "motor restlessness". All subscores are summed up into a total score. Total scores above 6 points are interpreted as a patient with severe pain, which would indicate a worse outcome.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Jul 2017
- Primary completion1 Jul 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Albert Sabin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, washington aspilicueta pinto filho, Hospital Infantil Albert Sabin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681574
- Sponsor's protocol ID
- HOSPITALIAS2
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
PubMed 20418301Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.
PubMed 25230144
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Gabapentin as Preanesthetic Medication in Oncologic Children Undergoing in Fast Procedures With Sevofluran
- ClinicalTrials.gov ID
- NCT03681574
- Acronym / sponsor ID
- HOSPITALIAS2
- Conditions
- Pain, Postoperative, Agitation States as Acute Reaction to Exceptional Stress, Anesthesia, Vomiting
- Keywords
- pediatric, gabapentin, agitation, induction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Hospital Infantil Albert SabinUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Sep 2018 (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 study is a clinical trial, prospective, randomized and double-blinded. Placebo, Gabapentin syrup at 15 mg/kg, and Gabapentin syrup at 30 mg/kg were administered to reduce agitation before and after in children submitted procedures (myelogram or lumbar puncture) among 1 and 6 years.
Detailed description
Gabapentin syrup at 15 mg/kg and at 30 mg/kg was administered to reduce the agitation before and after oncologic procedures (myelogram or lumbar puncture) in children among 1 and 6 years. Three groups were compared: the control group received placebo, the other two groups received gabapentin at 15mg/kg or at 30mg/kg. All patients received the same protocols (anesthesia and analgesia). Anesthesia protocol used was induction with sevoflurane 8% plus N2O 50% and oxygen, maintenance with sevoflurane 4%. We provided local analgesia with 5% lidocaine creme before the procedure. If it was required, dipyrone 10mg/kg every 6 hours was given as rescue analgesia. To prevent post-operative vomit, ondasentron 0,1mg/kg was administered when intrathecal chemotherapy. The mYPAS scale was used to evaluate preoperative anxiety at several moments: at basal, at after 1-hour administration, at separation from parents, and at induction. The PAED scale was applied after 30 minutes of procedure to evaluate postoperative agitation. The CHIPPS scale was used to assess postoperative pain. The frequency of vomits was recorded for 8 hours after the procedure finished.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Placebo Group | Experimental | Drug: Placebo GroupThe placebo group will receive placebo concentrate orally (0.3 mL/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture. |
| GABA 15mg/kg Group | Experimental | Drug: GABA 15mg/kg GroupThe GABA 15mg/kg group will receive gabapentin syrup orally (15 mg/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture. |
| GABA 30mg/kg Group | Experimental | Drug: GABA 30mg/kg GroupThe GABA 30mg/kg group will receive gabapentin syrup orally (30 mg/kg) only once, 1 to 2 hours before the oncologic procedure. All patients will undergo the same anesthetic protocol. Afterward, the patients will be submitted to oncologic procedures: Myelogram or Lumbar Puncture. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Cancer or under investigation for cancer.
- Children between 1 and 6 years.
- Previously submitted to oncologic procedures, e.g. myelogram or puncture lumbar.
Key exclusion criteria (6 listed)
- Cardiac disease.
- Pulmonary disease.
- Renal disease.
- Neurological disease.
- Any allergies.
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 |
|---|---|---|
| Placebo GroupAlso: Lumbar puncture, MyelogramPatients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive placebo concentrate. | Drug | Placebo Group |
| GABA 15mg/kg GroupAlso: Lumbar puncture, MyelogramPatients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 15mg/kg. | Drug | GABA 15mg/kg Group |
| GABA 30mg/kg GroupAlso: Lumbar puncture, MyelogramPatients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 30mg/kg. | Drug | GABA 30mg/kg Group |
Primary outcome
The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects.
Time frame: 8 hours
Children, ranging from 1 to 6 years old, will receive drugs (placebo, gabapentin 15mg/kg or 30mg/kg) 1 to 2 hours before the oncologic procedure (myelogram and/ or puncture lumbar). They will be submitted to the same general anesthesia protocol (sevoflurane 8% plus N2O and oxygen) and postoperative analgesia. All patients will be observed for changes in the Modified Yale Preoperative Anxiety Scale (mYPAS) at baseline (right before drug administration), at 1 hour after group administration, at the separation from parents, and at anesthetic induction time. The mYPAS scale is a compilation of 5 subscales: activity (0 to 4 points), vocalizations (0 to 6 points), emotional expressivity (0 to 4 points), state of apparent arousal (0 to 4 points), and use of parent (0 to 4 points). All scores are summed up, divided by 4, and then multiplied by 100. Total scores above 30 points are interpreted as a patient with anxiety, which would represent a worse outcome.
5 secondary outcomes
Percentage of sevoflurane consumption in patients over anesthetic induction.
Time frame: 8 hours
Level of emergence delirium and agitation in children at post-operative through Paediatric Anaesthesia Emergence Delirium.
Time frame: 1 hour
Frequency of post-operative vomits.
Time frame: 8 hours
Anesthetic induction time in seconds.
Time frame: 8 hours
Levels of postoperative pain in children through Children and Infants Postoperative Pain Scale (CHIPPS).
Time frame: 1 hour
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 27 Sep 2018.
- Results publication: PubMed 20418301Rusy LM, Hainsworth KR, Nelson TJ, Czarnecki ML, Tassone JC, Thometz JG, Lyon RM, Berens RJ, Weisman SJ. Gabapentin use in pediatric spinal fusion patients: a randomized, double-blind, controlled trial. Anesth Analg. 2010 May 1;110(5):1393-8. doi: 10.1213/ANE.0b013e3181d41dc2.
- Results publication: PubMed 25230144Mayell A, Srinivasan I, Campbell F, Peliowski A. Analgesic effects of gabapentin after scoliosis surgery in children: a randomized controlled trial. Paediatr Anaesth. 2014 Dec;24(12):1239-44. doi: 10.1111/pan.12524. Epub 2014 Sep 17.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 GABA 15mg/kg Group and GABA 30mg/kg Group in people with Pain, Postoperative and Agitation States as Acute Reaction to Exceptional Stress, run by Hospital Infantil Albert Sabin at 1 site in Brazil.
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 6 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 27 Sep 2018. 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 Brazil. 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.
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?
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?
The intensity of anxiety in children by Modified Yale Preoperative Anxiety Scale (mYPAS) before an oncologic procedure under Gabapentin or placebo effects. (time frame: 8 hours). 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 NCT03681574, which also lists 2 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 27 Sep 2018.