Does gabapentin decrease the incidence of postoperative pain in children undergoing tonsillectomy procedures?
A multi-centre, double-blinded randomised placebo-controlled study to investigate Gabapentin use to manage post tonsillectomy pain
The Kids Research Institute Australia
200 participants
Oct 6, 2021
Interventional
Conditions
Summary
Pain following tonsillectomy is a big problem for many children. At Perth Children’s Hospital as at other centres, there is a high rate of unplanned re-presentation to hospital with many of these visits due to pain. Some of the pain experienced by children after having their tonsils out is likely neuropathic in nature and less responsive to the standard pain killers which are currently prescribed. There are concerns about the use of the currently used pain relieving medicines for example regular anti-inflammatories in the setting of poor oral intake post operatively and worries over their effects on bleeding risk or the use of opioids in this population at risk of breathing difficulty. Studies to date using gabapentin (a well-known drug to treat neuropathic pain) preoperatively have been encouraging showing a reduction in early pain, strong pain killer requirement and of their side effects. There have been no studies in children using an extended course of the medicine. To help improve post-operative pain management we aim to assess the impact of perioperative gabapentin on postoperative pain levels through a placebo-controlled trial. We will also monitor the return to normal of a number of functional outcomes, for example, eating pattern, sleeping pattern, vomiting. If gabapentin is shown to be effective, then children will not only benefit from reduced pain but may also require less additional doses of breakthrough strong pain killers. Furthermore, better pain control will reduce the number of re-presentations to their general practitioners or hospital benefiting the Health System as a whole. We hypothesise that (1) Gabapentin will significantly decrease the postoperative child and parental reported pain scores following tonsillectomy. 2) Gabapentin will reduce the breakthrough opioid requirement in children following a tonsillectomy. 3) Gabapentin will reduce the medical re-attendance rate for pain following adenotonsillectomy.
Eligibility
Inclusion Criteria3
- Children aged 4-16 years
- Undergoing elective surgery under general anaesthetic for tonsillectomy +/- adenoidectomy +/- grommets or cautery inferior turbinates
- Staying overnight in hospital
Exclusion Criteria8
- Severe obstructive sleep apnoea documented on a sleep study
- Cardiovascular, respiratory or neurological disease giving an ASA III or above status
- Known renal impairment
- Regular preoperative use of anticonvulsants, analgesics or any concomitant use of central nervous system depressants
- Known hypersensitivity to the active substance or to any of the excipients listed
- Patients will be excluded if language barriers impede data collection or if the Department for Child Protection and Family Support is involved in their care
- Patients will be excluded if they have planned admissions to the Paediatric Intensive Care Unit (PICU)
- Current or previous mental health concerns
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Interventions
The study will be a randomized, double-blinded and placebo-controlled study. Following approval from the treating anaesthetist and voluntary written informed consent by the parent/guardian, the recruited children will be block randomised and assigned to one of the two groups, in a 1:1 ratio to receive either gabapentin (100mg/ml) suspension or placebo suspension. The blinding of the drug will be performed by the Clinical Trials Pharmacy who will provide us with the un-blinding folders/envelopes for the study. Participants, research assistants, nurses and doctors will be blinded to the allocation. We will call the study suspensions by the word syrup in our information sheets to the families in order to ensure readability and understanding of the study information. Participants will receive 0.06 ml/kg of their assigned suspension (rounded to the nearest 0.1 ml) for their first preoperative dose, approximately 45 minutes before induction. Subsequently, they will receive 0.03 ml/kg of their assigned suspension (rounded to the nearest 0.1 ml) three times a day by mouth on days 0, 1, & 2, which equates to 3 mg/kg dose gabapentin or placebo. They will receive at least 2 doses on Day 0 (DO) during their in-patient hospital stay and this will include the first preoperative dose. The dose will be titrated up to 0.06 ml/kg (6 mg/kg gabapentin if in the active group) three times daily from the morning of day 3, for days 3, 4 & 5. On day 6 & 7 the dose will reduce to previous 0.03 ml/kg three times daily before stopping on day 8. Participants will receive medication for 8 days (D0-D7). The study medications are in addition to the standard medications normally prescribed post tonsillectomy. There will be active follow up with the families to ensure study adherence. All families are provided with a standard diary to document medication administration following tonsillectomy surgery. Our families will also be provided with a study diary where they will document further information. They will also report this in the study database via survey links sent daily.
Locations(1)
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ACTRN12620000396921