Pain, PostoperativePhase 4NCT03005483
Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
A Phase 4 study testing Gabapentin in people with Pain, Postoperative and Orthopedic Disorder, run by Hospital Infantil Albert Sabin at 1 site in Brazil.
Trial summary
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. Read more about this study
- Who is it for?
- Ages 3 months to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Orthopedic Disorder
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to May 2016
- 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 3 months to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery
Who cannot join
- Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.
Read the detailed description
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .
- Conditions
- Pain, Postoperative, Orthopedic Disorder
- Being tested
- Gabapentin, Placebo
- Keywords
- GABAPENTIN POSTOPERATIVE PAIN CHILD
- Medical subject headings
- Pain, Postoperative, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called Orthopedic Surgery
Orthopedic Surgery was applied for the treatment of osseous disorders
PlaceboOther
Orthopedic Surgery was applied for the treatment of osseous disorders
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin 10 mg/kg in children submitted unilateral limb surgery Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Placebo in children submitted unilateral limb surgery Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduce the pain intensity using the Face Pain Scale
Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.
Measured: 24 hour
Secondary outcomes (1)
Reduce the opioid consumption through 24 hours postoperative observation
Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was administered morphine 50mcg / kg (maximum dose of 2mg) up to 2 / 2h when Face´s Scales reached 5 points.
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startJan 2014
- Primary completionJan 2015
- Study completionMay 2016
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Infantil Albert Sabin
- Sponsor type
- University, hospital or other
- Collaborators
- Fortaleza University
- Responsible party
- Principal investigator, washington aspilicueta pinto filho, Hospital Infantil Albert Sabin
- Investigators
- Josenília Gomes, PhD, Study chair, Fortaleza University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03005483
- Sponsor's protocol ID
- HOSPITALIAS
- Status last verified
- Dec 2016
- First submitted
- 13 Dec 2016
- Last updated
- 29 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo Controlled, Randomized,Gabapentin as Adjuvant for Postoperative Pain in Pediatric Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT03005483
- Acronym / sponsor ID
- HOSPITALIAS
- Conditions
- Pain, Postoperative, Orthopedic Disorder
- Keywords
- GABAPENTIN POSTOPERATIVE PAIN CHILD
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Infantil Albert SabinUniversity, hospital or other
- Collaborators
- Fortaleza University
- Study start
- Jan 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 29 Dec 2016 (estimated)
- 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. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery.
Detailed description
This study is a clinical trial, prospective, randomized and double-blinded. Gabapentin oral 10 mg/kg was administered to reduce the pain intensity as well as the opioid consumption in children from 3 months to 16 years submitted unilateral limb surgery. The children were divided into 2 groups: the gabapentin group (GG) was administered gabapentin 1 to 2 hours before procedure (N-40) and the placebo group (GP) was administered placebo 1 to 2 hours before surgery (N-44). Both groups were subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%. All patients received dipyrone and rescue analgesic used was morphine into 2/2h. The variables studied were age, gender, weight, type of surgery, hemodynamics, postoperative pain and morphine consumption .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Experimental | Drug: GabapentinGabapentin 10 mg/kg in children submitted unilateral limb surgery |
| Placebo | Placebo comparator | Other: PlaceboPlacebo in children submitted unilateral limb surgery |
Who may qualify
- Ages
- 3 months to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children between 3 months and 16 years who were previously healthy submitted to unilateral lower limb surgery
Key exclusion criteria (1 listed)
- Children cardiac, pulmonary, renal and neurological diseases and allergy and refusal of parents, caregivers and patients to participate in the study.
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 |
|---|---|---|
| GabapentinAlso: Orthopedic SurgeryOrthopedic Surgery was applied for the treatment of osseous disorders | Drug | Gabapentin |
| PlaceboOrthopedic Surgery was applied for the treatment of osseous disorders | Other | Placebo |
Primary outcome
Reduce the pain intensity using the Face Pain Scale
Time frame: 24 hour
Subjected to the same general anesthesia protocol, opioid free, and femoral and sciatic block with bupivacaine 0.125%.The evaluation times were: 1 hour, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours after surgery. The time elapsed was recorded, from the end of the surgery to the first use of morphine. The parents and the patients themselves were instructed to request analgesic at any time.
1 secondary outcome
Reduce the opioid consumption through 24 hours postoperative observation
Time frame: 24 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 29 Dec 2016.
- Background: 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.
- Background: 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.
Josenília Gomes, PhD study chair
Fortaleza 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 Gabapentin in people with Pain, Postoperative and Orthopedic Disorder, 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 1 inclusion and 1 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 29 Dec 2016. 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. 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?
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?
Reduce the pain intensity using the Face Pain Scale (time frame: 24 hour). 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 NCT03005483, 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 29 Dec 2016.