Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Effect of Sumatriptan on the Postoperative Quality of Recovery After Elective Minimally Invasive Craniotomy
Brief Summary: Postoperative migrainous headache following craniotomy is distressing and may cause significant morbidity and often delay discharge from the hospital. The mechanism of this post craniotomy migraine is multifactorial. Possible causes include the intraoperative loss of cerebrospinal fluid leading to stretching of the dura, traction on intracranial vessels and meningeal irritation. There are two groups of patients who undergo elective minimally invasive craniotomies and yet have considerable postoperative migraine headache postoperatively. These are patients who have a craniotomy for clipping of an unruptured cerebral aneurysm and patients who require a microvascular decompressive craniotomy for cranial nerve pain such as trigeminal neuralgia. Their postoperative migrainous headache often impairs the quality of their recovery and may even delay discharge from hospital. Opioid analgesics are not always effective and may also worsen the postoperative nausea and vomiting and in turn postoperative quality of their recovery. Sumatriptan is a drug that has been used for decades for the treatment of migraine headaches. It acts on 5hydroxytryptophan receptors, which are located in the dura mater (lining of the brain) and are also located around the cranial trigeminal nerve ganglion. Thus sumatriptan may be an effective to improve postoperative migraine , nausea and vomiting and overall quality of recovery. We plan to do a randomized double blind placebo controlled trial on the effect of Sumatriptan for postoperative migraine on the postoperative quality of recovery after elective minimally invasive craniotomies. A total of 92 patients scheduled to undergo minimally invasive craniotomy for either clipping of an unruptured aneurysm or microvascular decompression for cranial nerve neuralgias will be included in this study. Patients within the 2 surgical groups with postoperative migraine will then be block randomized to receive either 6mg of sumatriptan subcutaneously or placebo following assessment in the post operative care unit (PACU). The primary outcome measure will be quality of recovery at 24 hours using Quality of recovery 40 Questionnaire (QoR-40). Our secondary outcome will be postoperative pain, analgesic consumption, side effects and hospital discharge times.


Options:
A: Arm Label: Intervention group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intravenous acetaminophen | Arm Label: Placebo Group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo for IV acetaminophen | Intervention Type: DRUG; Name: Intravenous acetaminophen; Assigned to Arm(s): Intervention group | Intervention Type: DRUG; Name: Placebo for IV acetaminophen; Assigned to Arm(s): Placebo Group
B: Arm Label: IV Caldolor (ibuprofen); Type: ACTIVE_COMPARATOR; Interventions: Drug: IV Caldolor | Arm Label: standard treatment group; Type: PLACEBO_COMPARATOR; Interventions: Drug: IV Placebo | Intervention Type: DRUG; Name: IV Caldolor; Assigned to Arm(s): IV Caldolor (ibuprofen) | Intervention Type: DRUG; Name: IV Placebo; Assigned to Arm(s): standard treatment group
C: Arm Label: 1; Type: PLACEBO_COMPARATOR; Interventions: Drug: Intravenous Parecoxib ('Dynastat' Pfizer) | Arm Label: 2; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intravenous Parecoxib ('Dynastat' Pfizer) | Intervention Type: DRUG; Name: Intravenous Parecoxib ('Dynastat' Pfizer); Assigned to Arm(s): 1, 2
D: Arm Label: Sumatriptan; Type: EXPERIMENTAL; Interventions: Drug: Sumatriptan, Other: Placebo | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Sumatriptan, Other: Placebo | Intervention Type: DRUG; Name: Sumatriptan; Assigned to Arm(s): Placebo, Sumatriptan | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo, Sumatriptan

Answer: D