Post Operative Nausea and Vomiting (PONV)Phase 3NCT02384187
Gabapentin Premedication and Adenotonsillectomy in Pediatric Patients
A Phase 3 study testing Gabapentin as premedication in people with Post Operative Nausea and Vomiting (PONV) and Adenotonsillectomy, run by Cairo University at 1 site in Egypt.
Trial summary
The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Read more about this study
- Who is it for?
- Ages 3 to 12 years
- Conditions the study is for
- Post Operative Nausea and Vomiting (PONV), Adenotonsillectomy
- What is being tested?
- Gabapentin as premedication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Aug 2015
- Phase
- Phase 3
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged (3-12)
- ASA physical status I or II
- Scheduled for adenotonsillectomy surgery in Abu Elrish Al-Mounira Hospital
Who cannot join
- Patients who have active infection
- Obstructive sleep apnea
- Cognitive impairment
- Abnormal bleeding profile
- Renal or hepatic dysfunction
- History of allergic reaction to study medications or chronic use of anti-consultants will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Oral Gabapentin Premedication on Postoperative Nausea and Vomiting and Early Postoperative Recovery Profile in Pediatric Patients Undergoing Adenotonsillectomy
The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of patients, with a reported incidence ranging from 23% to 73%.
There is growing evidence that the perioperative administration of gabapentinin in adults is beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative nausea and vomiting, and delirium.
Only few studies in literature explored the analgesic effects of preoperative gabapentin as premedication in pediatric population. However, the antiemetic effect of gabapentin in pediatric patients was not systematically investigated before.
- Being tested
- Gabapentin as premedication, placebo
- Keywords
- Gabapentin, PONV, Adenotonsillectomy, Pediatrics
- Medical subject headings
- Vomiting, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin as premedicationDrug
Patients will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia
placeboDrug
Patients will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Patients in this group will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia. Receives: Drug: placebo |
| Group GAB | Experimental | Patients in this group will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia Receives: Drug: Gabapentin as premedication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of PONV
The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively
Measured: over the first postoperative 6 hours
Secondary outcomes (6)
Pediatric Anesthesia Behavior score (PAB)
the score will be assessed during induction of anesthesia. The child will be scored 1 if Happy; 2 if Sad; and 3 if Mad.
Measured: within10 minutes before the child falls asleep.
Incidence and severity of postoperative delirium
Emergence agitation scores will be recorded every10 min for the first 60 minutes postoperatively
Measured: up to 60 minutes after the end of the operation.
Duration of recovery
The extubation time will be the time interval from discontinuation of sevoflurane until removal of the endotracheal tube. The time to interaction will be the time from discontinuation of sevoflurane until verbal contact or response to commands.
Measured: up to 60 minutes after the end of surgery.
Time to first request of postoperative rescue analgesics.
the time interval between the end of surgery and the first request to postoperative analgesia
Measured: over the first postoperative 6 hours
Postoperative analgesic consumption
Measured: over the first postoperative 6 hours
Objective pain scale (OPS)
The objective pain scale will be assessed at 30 minutes, 2, 4 and 6 hours postoperatively.
Measured: over the first postoperative 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionMay 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Nausea and Vomiting (PONV)Studies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba mohamed nassar, Cairo University
- Investigators
- Mohamed Abdulatif, Professor of Anesthesia, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02384187
- Sponsor's protocol ID
- N-47-2014
- Status last verified
- Dec 2015
- First submitted
- 20 Feb 2015
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Oral Gabapentin Premedication on Postoperative Nausea and Vomiting and Early Postoperative Recovery Profile in Pediatric Patients Undergoing Adenotonsillectomy
- ClinicalTrials.gov ID
- NCT02384187
- Acronym / sponsor ID
- N-47-2014
- Keywords
- Gabapentin, PONV, Adenotonsillectomy, Pediatrics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- May 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 10 Mar 2015 (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.
The frequent incidence of postoperative vomiting and severe pain in children undergoing adenotonsillectomy, may delay postoperative oral intake and increase the risk of dehydration. Postoperative nausea and vomiting (PONV) is of multi-factorial origin in this group of patients, with a reported incidence ranging from 23% to 73%.
There is growing evidence that the perioperative administration of gabapentinin in adults is beneficial for preoperative anxiolysis, postoperative analgesia, reduction of postoperative nausea and vomiting, and delirium.
Only few studies in literature explored the analgesic effects of preoperative gabapentin as premedication in pediatric population. However, the antiemetic effect of gabapentin in pediatric patients was not systematically investigated before.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: placeboPatients in this group will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia. |
| Group GAB | Experimental | Drug: Gabapentin as premedicationPatients in this group will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Aged (3-12)
- ASA physical status I or II
- Scheduled for adenotonsillectomy surgery in Abu Elrish Al-Mounira Hospital
Key exclusion criteria (6 listed)
- Patients who have active infection
- Obstructive sleep apnea
- Cognitive impairment
- Abnormal bleeding profile
- Renal or hepatic dysfunction
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 |
|---|---|---|
| Gabapentin as premedicationPatients will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia | Drug | Group GAB |
| placeboPatients will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia. | Drug | Group C |
Primary outcome
Incidence of PONV
Time frame: over the first postoperative 6 hours
The number of patient complaints of nausea and or vomiting will be recorded in the first 6 hours postoperatively
6 secondary outcomes
Pediatric Anesthesia Behavior score (PAB)
Time frame: within10 minutes before the child falls asleep.
Incidence and severity of postoperative delirium
Time frame: up to 60 minutes after the end of the operation.
Duration of recovery
Time frame: up to 60 minutes after the end of surgery.
Time to first request of postoperative rescue analgesics.
Time frame: over the first postoperative 6 hours
Postoperative analgesic consumption
Time frame: over the first postoperative 6 hours
Objective pain scale (OPS)
Time frame: over the first postoperative 6 hours
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 23 Dec 2015.
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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.
Mohamed Abdulatif, Professor of Anesthesia study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin as premedication in people with Post Operative Nausea and Vomiting (PONV) and Adenotonsillectomy, run by Cairo University at 1 site 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 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 23 Dec 2015. 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 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Incidence of PONV (time frame: over the first postoperative 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Dec 2015.